K000712 is an FDA 510(k) clearance for the PORTABLE INTENSIVE CARE UNIT, MODEL PIC. This device is classified as a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II - Special Controls, product code CCK).
Submitted by Medical Research Laboratories, Inc. (Buffalo Grove, US). The FDA issued a Cleared decision on April 27, 2000, 56 days after receiving the submission on March 2, 2000.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1400.
| 510(k) Number | K000712 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 2000 |
| Decision Date | April 27, 2000 |
| Days to Decision | 56 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | CCK — Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1400 |