K082478 is an FDA 510(k) clearance for the WELCH ALLYN CARDIOPERFECT WORKSTATION SOFTWARE (CPWS) V 1.62. This device is classified as a Spirometer, Diagnostic (Class II - Special Controls, product code BZG).
Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on March 9, 2009, 193 days after receiving the submission on August 28, 2008.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1840.
| 510(k) Number | K082478 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 2008 |
| Decision Date | March 09, 2009 |
| Days to Decision | 193 days |
| Submission Type | Abbreviated |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZG — Spirometer, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1840 |