# K971813: EMBLA

- Pathway: 510(k) (Traditional)
- Applicant: Ferguson Medical
- Decided: Jan 16, 1998 after 245 days
- Product code: OLV (Standard Polysomnograph With Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K830295 (1983). 8 ancestors in all.
61 later devices descend from it; 7 cite it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922106: ALICE, Healthdyne, Inc. (1994) Summary page 1.
- K971867: Alice 4R System, Healthdyne Technologies, Inc. (1997). Cleared while this submission was under review Summary page 1.
- K915856: Sensormedics 4000 Series Sleep System, Sensor Medics Corp. (1992) Summary page 1.
- K910771: Digitrace (TM) Home Monit Comp/Elb (TM) Eeg Lunch BX, New England Medical Instruments, Inc. (1991) Summary page 1.
- K944833: Digitrace Sleep Computer, Sleeppac, Home Sleep System, New England Medical Monitoring Co. (1995) Summary page 1.
- K946094: Cadwell Easy Ambulatory Eeg, Cadwell Laboratories, Inc. (1995) Summary page 1.
- K830295: Medilog 9000 System, Oxford Medilog, Inc. (1983) Summary page 1.
- K860456: Model 9000 Recording & Electrophysiological System, Oxford Medilog, Inc. (1986) Summary page 1.

## Most influential descendants
- K080427: Watch-Pat Model 100S-2 (2008), 25 descendants of its own
- K081982: Watch-Pat 200S-2 (WP200S-2) (2008), 24 descendants of its own
- K102567: Watch-Pat 200S-3 (WP200S-3) (2011), 23 descendants of its own
- K070375: Earlysense ES-16 System (2007), 23 descendants of its own
- K133859: Watch-PAT200U (WP200U) (2014), 22 descendants of its own

## Indications for use
Embla is a polysomnographic system that is intended to record, display, and print EEG and other physiological information to clinicians/physicians. The device will be used in hospitals, institutions, sleep centers or clinics, or other test environments where patients require documentation of various sleep or other physiological disorders.

Source page: https://510kreport.com/device/K971813
Methodology: https://510kreport.com/methodology