K020797 is an FDA 510(k) clearance for the PULMO-MIST COMPRESSOR MODEL # 4323. This device is classified as a Compressor, Air, Portable (Class II - Special Controls, product code BTI).
Submitted by Nidek Medical Products, Inc. (Birmingham, US). The FDA issued a Cleared decision on May 3, 2002, 52 days after receiving the submission on March 12, 2002.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.6250.
| 510(k) Number | K020797 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 12, 2002 |
| Decision Date | May 03, 2002 |
| Days to Decision | 52 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BTI - Compressor, Air, Portable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.6250 |