K802920 is an FDA 510(k) clearance for the INSPIRON PULMONARY FUNCTION ANALYZER. This device is classified as a Calculator, Pulmonary Function Data (Class II - Special Controls, product code BZC).
Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 23, 1981, 97 days after receiving the submission on November 18, 1980.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1880.
| 510(k) Number | K802920 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 1980 |
| Decision Date | February 23, 1981 |
| Days to Decision | 97 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BZC — Calculator, Pulmonary Function Data |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1880 |