# K972515: Sensor Amplifier

- Pathway: 510(k) (Traditional)
- Applicant: Pro-Tech Services, Inc.
- Decided: Oct 2, 1997 after 91 days
- Product code: GWL (Amplifier, Physiological Signal)
- Device class: 2
- Regulation: 21 CFR 882.1835
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
TO PROVIDE AN AMPLIFYING INTERFACE BETWEEN PRO-TECH SENSOR OUTPUT AND CUSTOMER RECORDING EQUIPMENT INPUT, THE SENSOR AMPLIFIER IS TO BE USED WITH SUB TEERS (Ch‘/c,DkrflJ E/fiouw—) WHERE THE RECORDING EQUIPMENT REQUIRES A HIGH INPUT SIGNAL. THE DO (S N D U FoR. SLEY®P (ABS .

Source page: https://510kreport.com/device/K972515
Methodology: https://510kreport.com/methodology