The following data is part of a premarket notification filed by Warren E. Collins, Inc. with the FDA for Apexline Of Pulmonary Funct. Instrum..
| Device ID | K803053 |
| 510k Number | K803053 |
| Device Name: | APEXLINE OF PULMONARY FUNCT. INSTRUM. |
| 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 | 1980-12-02 |
| Decision Date | 1980-12-22 |