The following data is part of a premarket notification filed by Instrumentation Industries, Inc. with the FDA for Oxygen Enrichment Kit, Models Sg 066, Sg 067.
| Device ID | K992670 |
| 510k Number | K992670 |
| Device Name: | OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067 |
| Classification | Ventilator, Continuous, Facility Use |
| 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 | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-21 |
| Decision Date | 1999-09-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M996SG0660 | K992670 | 000 |