The following data is part of a premarket notification filed by Instrumentation Industries, Inc. with the FDA for Exhalation Valve (be 30-115-b, Ns 30-115-u, Ns 30-115-5, Ps 54-a).
| Device ID | K980725 |
| 510k Number | K980725 |
| Device Name: | EXHALATION VALVE (BE 30-115-B, NS 30-115-U, NS 30-115-5, PS 54-A) |
| Classification | Valve, Non-rebreathing |
| 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 | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-24 |
| Decision Date | 1998-08-24 |