K980878 is an FDA 510(k) clearance for the PULMOTRACK,MODEL 1010. This device is classified as a Calculator, Pulmonary Function Interpretor (diagnostic) (Class II - Special Controls, product code BZM).
Submitted by Karmel Medical Acoustic Technologies , Ltd. (Tirat Hacarmel, IL). The FDA issued a Cleared decision on December 28, 1998, 294 days after receiving the submission on March 9, 1998.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1900.
| 510(k) Number | K980878 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 09, 1998 |
| Decision Date | December 28, 1998 |
| Days to Decision | 294 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZM — Calculator, Pulmonary Function Interpretor (diagnostic) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1900 |