K053232 is an FDA 510(k) clearance for the PRECISION BLENDER. This device is classified as a Mixer, Breathing Gases, Anesthesia Inhalation (Class II - Special Controls, product code BZR).
Submitted by Precision Medical, Inc. (Northampton, US). The FDA issued a Cleared decision on January 10, 2006, 53 days after receiving the submission on November 18, 2005.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5330.
| 510(k) Number | K053232 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 2005 |
| Decision Date | January 10, 2006 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZR — Mixer, Breathing Gases, Anesthesia Inhalation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5330 |