K823555 is an FDA 510(k) clearance for the MAGTARAK RESPIRATORY MONITOR & FLOW SENS. This device is classified as a Spirometer, Monitoring (w/wo Alarm) (Class II - Special Controls, product code BZK).
Submitted by Penlon, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 5, 1983, 35 days after receiving the submission on December 1, 1982.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1850.
| 510(k) Number | K823555 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 01, 1982 |
| Decision Date | January 05, 1983 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BZK — Spirometer, Monitoring (w/wo Alarm) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1850 |