K861929 is an FDA 510(k) clearance for the PULMONARY FUNCTION TEST LABORATORY, SYSTEM 1070. This device is classified as a Calculator, Pulmonary Function Interpretor (diagnostic) (Class II - Special Controls, product code BZM).
Submitted by Medical Graphics Corp. (St. Paul, US). The FDA issued a Cleared decision on September 26, 1986, 129 days after receiving the submission on May 20, 1986.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1900.
| 510(k) Number | K861929 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | May 20, 1986 |
| Decision Date | September 26, 1986 |
| Days to Decision | 129 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BZM — Calculator, Pulmonary Function Interpretor (diagnostic) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1900 |