K883384 is an FDA 510(k) clearance for the TS1000 SUCTION TIP. This device is classified as a Catheters, Suction, Tracheobronchial (Class I - General Controls, product code BSY).
Submitted by M.D. Engineering, Inc. (Hayward, US). The FDA issued a Cleared decision on November 2, 1988, 85 days after receiving the submission on August 9, 1988.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.6810.
| 510(k) Number | K883384 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 1988 |
| Decision Date | November 02, 1988 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BSY — Catheters, Suction, Tracheobronchial |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.6810 |