The following data is part of a premarket notification filed by International Respiratory Systems, Inc. with the FDA for Peep Valve.
| Device ID | K923618 |
| 510k Number | K923618 |
| Device Name: | PEEP VALVE |
| Classification | Attachment, Breathing, Positive End Expiratory Pressure |
| Applicant | INTERNATIONAL RESPIRATORY SYSTEMS, INC. 386 BROADWAY 2ND FLR Newburgh, NY 12550 |
| Contact | Sheehan Iii |
| Correspondent | Sheehan Iii INTERNATIONAL RESPIRATORY SYSTEMS, INC. 386 BROADWAY 2ND FLR Newburgh, NY 12550 |
| Product Code | BYE |
| CFR Regulation Number | 868.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-21 |
| Decision Date | 1992-08-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10709078004664 | K923618 | 000 |
| 10709078000659 | K923618 | 000 |
| 10709078000642 | K923618 | 000 |
| 10709078000376 | K923618 | 000 |
| 10709078000369 | K923618 | 000 |