K840453 is an FDA 510(k) clearance for the MEDISHIELD PVM RESPIROMETER. This device is classified as a Spirometer, Monitoring (w/wo Alarm) (Class II - Special Controls, product code BZK).
Submitted by Ohio Medical Products (Mchenry, US). The FDA issued a Cleared decision on March 2, 1984, 30 days after receiving the submission on February 1, 1984.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1850.
| 510(k) Number | K840453 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 1984 |
| Decision Date | March 02, 1984 |
| Days to Decision | 30 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 |