The following data is part of a premarket notification filed by Warren E. Collins, Inc. with the FDA for Collins Eagle Ii.
| Device ID | K831779 |
| 510k Number | K831779 |
| Device Name: | COLLINS EAGLE II |
| Classification | Calculator, Pulmonary Function Data |
| Applicant | WARREN E. COLLINS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BZC |
| CFR Regulation Number | 868.1880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-02 |
| Decision Date | 1983-08-26 |