K900315 is an FDA 510(k) clearance for the PERCUSSIONAIRE TXP TRANSPORTER/RESPIRATORS 750 MIN. This device is classified as a Ventilator, Continuous, Facility Use (Class II - Special Controls, product code CBK).
Submitted by Percussionaire Corp. (Sandpoint, US). The FDA issued a Cleared decision on October 26, 1990, 277 days after receiving the submission on January 22, 1990.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K900315 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | January 22, 1990 |
| Decision Date | October 26, 1990 |
| Days to Decision | 277 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CBK — Ventilator, Continuous, Facility Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5895 |