K073155 is an FDA 510(k) clearance for the VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6). This device is classified as a Spirometer, Diagnostic (Class II - Special Controls, product code BZG).
Submitted by Vitalograph (Ireland) , Ltd. (Ennis, Co. Clare, IE). The FDA issued a Cleared decision on June 4, 2008, 209 days after receiving the submission on November 8, 2007.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1840.
| 510(k) Number | K073155 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 2007 |
| Decision Date | June 04, 2008 |
| Days to Decision | 209 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZG — Spirometer, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1840 |