The following data is part of a premarket notification filed by Warren E. Collins, Inc. with the FDA for Pulmonary Function Tester.
| Device ID | K780584 |
| 510k Number | K780584 |
| Device Name: | PULMONARY FUNCTION TESTER |
| Classification | Calculator, Predicted Values, Pulmonary Function |
| Applicant | WARREN E. COLLINS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BTY |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-04-11 |
| Decision Date | 1978-05-16 |