K052158 is an FDA 510(k) clearance for the WELCH ALLYN CARDIOPERFECT WORKSTATION VERSION 1.5.0 SOFTWARE. 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 September 8, 2005, 30 days after receiving the submission on August 9, 2005.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1840.
| 510(k) Number | K052158 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 2005 |
| Decision Date | September 08, 2005 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZG — Spirometer, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1840 |