# K971808: Space Chamber for Model Number and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Monarch Medical
- Decided: Sep 26, 1997 after 134 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- 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
The space chamber obtains maximum benefit from your M.D.I. It improves delivery to lungs and reduces the amount of drug deposited in the throat. The space chamber can be used by all patients from the youngest neonate to an adult. The device can be used in hospital home and is portable and can be carried by the patient. The space chamber is a multipatient use device. Please follow cleaning instructions between patient use.

Source page: https://510kreport.com/device/K971808
Methodology: https://510kreport.com/methodology