The following data is part of a premarket notification filed by Chesebrough-pond's U.s.a. Co. with the FDA for Respirodyne Pulmonary Function Test.
| Device ID | K834475 |
| 510k Number | K834475 |
| Device Name: | RESPIRODYNE PULMONARY FUNCTION TEST |
| Classification | Spirometer, Diagnostic |
| Applicant | CHESEBROUGH-POND'S U.S.A. CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-20 |
| Decision Date | 1984-02-17 |