The following data is part of a premarket notification filed by Engineered Medical Systems with the FDA for Ems Peep Valves- Adjustable.
| Device ID | K983920 |
| 510k Number | K983920 |
| Device Name: | EMS PEEP VALVES- ADJUSTABLE |
| Classification | Attachment, Breathing, Positive End Expiratory Pressure |
| Applicant | ENGINEERED MEDICAL SYSTEMS 8529 ZIONSVILLE RD. P.O. BOX 681514 Indianapolis, IN 46268 |
| Contact | Jeff Quinn |
| Correspondent | Jeff Quinn ENGINEERED MEDICAL SYSTEMS 8529 ZIONSVILLE RD. P.O. BOX 681514 Indianapolis, IN 46268 |
| Product Code | BYE |
| CFR Regulation Number | 868.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-04 |
| Decision Date | 1999-01-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841470111066 | K983920 | 000 |
| 10841470111059 | K983920 | 000 |
| 10841470111042 | K983920 | 000 |
| 10841470111028 | K983920 | 000 |
| 10841470111011 | K983920 | 000 |
| 10841470111004 | K983920 | 000 |
| 10841470110991 | K983920 | 000 |
| 10841470110984 | K983920 | 000 |
| 10841470111035 | K983920 | 000 |