The following data is part of a premarket notification filed by Warren E. Collins, Inc. with the FDA for Collins Pneumotach Pft System.
| Device ID | K861227 |
| 510k Number | K861227 |
| Device Name: | COLLINS PNEUMOTACH PFT SYSTEM |
| Classification | Spirometer, Diagnostic |
| Applicant | WARREN E. COLLINS, INC. 220 WOOD RD. Braintree, MA 02184 -2408 |
| Contact | James Tully |
| Correspondent | James Tully WARREN E. COLLINS, INC. 220 WOOD RD. Braintree, MA 02184 -2408 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-01 |
| Decision Date | 1986-06-05 |