The following data is part of a premarket notification filed by Chesebrough-pond's U.s.a. Co. with the FDA for Voldyne Volumetric Incentive Deep Br. Ex.
| Device ID | K801199 |
| 510k Number | K801199 |
| Device Name: | VOLDYNE VOLUMETRIC INCENTIVE DEEP BR. EX |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | CHESEBROUGH-POND'S U.S.A. CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BWF |
| CFR Regulation Number | 868.5690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-19 |
| Decision Date | 1980-06-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 34026704630227 | K801199 | 000 |
| 24026704391831 | K801199 | 000 |
| 24026704596991 | K801199 | 000 |
| 24026704597004 | K801199 | 000 |
| 24026704597011 | K801199 | 000 |
| 40801902124638 | K801199 | 000 |
| 34026704630173 | K801199 | 000 |
| 34026704630180 | K801199 | 000 |
| 34026704630197 | K801199 | 000 |
| 34026704630203 | K801199 | 000 |
| 34026704630210 | K801199 | 000 |
| 24026704391824 | K801199 | 000 |