The following data is part of a premarket notification filed by Instrumentation Industries, Inc. with the FDA for Sg-066 Oxygen Enrichment Kit.
| Device ID | K860077 |
| 510k Number | K860077 |
| Device Name: | SG-066 OXYGEN ENRICHMENT KIT |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | INSTRUMENTATION INDUSTRIES, INC. 2990 INDUSTRIAL BLVD. Bethel Park, PA 15102 |
| Contact | Clyde T Marrangoni |
| Correspondent | Clyde T Marrangoni 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 | 1986-01-08 |
| Decision Date | 1986-02-18 |