The following data is part of a premarket notification filed by Instrumentation Industries, Inc. with the FDA for Reusable, Adjustable, Magnetic Peep Valve Be 142.
| Device ID | K963347 |
| 510k Number | K963347 |
| Device Name: | REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142 |
| Classification | Attachment, Breathing, Positive End Expiratory Pressure |
| Applicant | INSTRUMENTATION INDUSTRIES, INC. 2990 INDUSTRIAL BLVD. Bethel Park, PA 15102 |
| Contact | Lori Zuravleff |
| Correspondent | Lori Zuravleff INSTRUMENTATION INDUSTRIES, INC. 2990 INDUSTRIAL BLVD. Bethel Park, PA 15102 |
| Product Code | BYE |
| CFR Regulation Number | 868.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-26 |
| Decision Date | 1997-03-19 |