The following data is part of a premarket notification filed by Instrumentation Industries, Inc. with the FDA for Manual Jet Ventilator (with Regulator And Gauge), Manual Jet Ventilator (without Regulator And Gauge), Models Be 183-sur.
| Device ID | K991785 |
| 510k Number | K991785 |
| Device Name: | MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | INSTRUMENTATION INDUSTRIES, INC. 2990 INDUSTRIAL BLVD. Bethel Park, PA 15102 |
| Contact | Tricia Wood |
| Correspondent | Tricia Wood INSTRUMENTATION INDUSTRIES, INC. 2990 INDUSTRIAL BLVD. Bethel Park, PA 15102 |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-25 |
| Decision Date | 1999-08-17 |