K803053 is an FDA 510(k) clearance for the APEXLINE OF PULMONARY FUNCT. INSTRUM.. This device is classified as a Calculator, Predicted Values, Pulmonary Function (Class II - Special Controls, product code BTY).
Submitted by Warren E. Collins, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 22, 1980, 20 days after receiving the submission on December 2, 1980.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1890.
| 510(k) Number | K803053 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 1980 |
| Decision Date | December 22, 1980 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BTY — Calculator, Predicted Values, Pulmonary Function |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1890 |