The following data is part of a premarket notification filed by Instrumentation Industries, Inc. with the FDA for Instant Flow Vavle (flowmeter, Pole, Rail, Wall Mount).
| Device ID | K970959 |
| 510k Number | K970959 |
| Device Name: | INSTANT FLOW VAVLE (FLOWMETER, POLE, RAIL, WALL MOUNT) |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| 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 | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-17 |
| Decision Date | 1997-06-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M996NP10002D5 | K970959 | 000 |
| M996BE3000WM0 | K970959 | 000 |
| M996BE3000RS0 | K970959 | 000 |
| M996BE3000RA0 | K970959 | 000 |
| M996BE3000PS0 | K970959 | 000 |
| M996BE3000PA0 | K970959 | 000 |
| M996BE3000FS0 | K970959 | 000 |
| M996BE3000FA0 | K970959 | 000 |
| M996BE100020 | K970959 | 000 |