K893420 is an FDA 510(k) clearance for the MASTERLAB PFT AND MASTERLAB BODY BOX. This device is classified as a Plethysmograph, Pressure (Class II - Special Controls, product code CCM).
Submitted by Quinton, Inc. (Seattle, US). The FDA issued a Cleared decision on June 23, 1989, 57 days after receiving the submission on April 27, 1989.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1750.
| 510(k) Number | K893420 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 1989 |
| Decision Date | June 23, 1989 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CCM — Plethysmograph, Pressure |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1750 |