The following data is part of a premarket notification filed by Instrumentation Industries, Inc. with the FDA for Auto-peep Measurement Device, Model # Kc 9-p.
| Device ID | K983631 |
| 510k Number | K983631 |
| Device Name: | AUTO-PEEP MEASUREMENT DEVICE, MODEL # KC 9-P |
| Classification | Valve, Non-rebreathing |
| Applicant | INSTRUMENTATION INDUSTRIES, INC. 2990 INDUSTRIAL BLVD. Bethel Park, PA 15102 |
| Contact | Edward C Horey, Jr. |
| Correspondent | Edward C Horey, Jr. INSTRUMENTATION INDUSTRIES, INC. 2990 INDUSTRIAL BLVD. Bethel Park, PA 15102 |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-15 |
| Decision Date | 1999-07-01 |