The following data is part of a premarket notification filed by Chesebrough-pond's U.s.a. Co. with the FDA for Respiradyne Ii(tm).
| Device ID | K863866 |
| 510k Number | K863866 |
| Device Name: | RESPIRADYNE II(TM) |
| Classification | Spirometer, Monitoring (w/wo Alarm) |
| Applicant | CHESEBROUGH-POND'S U.S.A. CO. TRUMBULL INDUSTRIAL PARK Trumbull, CT 06611 |
| Contact | Ronald E Mccarley |
| Correspondent | Ronald E Mccarley CHESEBROUGH-POND'S U.S.A. CO. TRUMBULL INDUSTRIAL PARK Trumbull, CT 06611 |
| Product Code | BZK |
| CFR Regulation Number | 868.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-03 |
| Decision Date | 1987-01-28 |