K896923 is an FDA 510(k) clearance for the INTERTECH/INSPIRON (R) MEDICATION NEBULIZER KIT. This device is classified as a Nebulizer (direct Patient Interface) (Class II - Special Controls, product code CAF).
Submitted by Intertech Resources, Inc. (Fort Myers, US). The FDA issued a Cleared decision on March 12, 1990, 90 days after receiving the submission on December 12, 1989.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K896923 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | December 12, 1989 |
| Decision Date | March 12, 1990 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CAF — Nebulizer (direct Patient Interface) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5630 |