The following data is part of a premarket notification filed by Waters Instruments, Inc. with the FDA for Mvp - 6000.
| Device ID | K852909 |
| 510k Number | K852909 |
| Device Name: | MVP - 6000 |
| Classification | Calculator, Pulmonary Function Data |
| Applicant | WATERS INSTRUMENTS, INC. 2411 SEVENTH ST. N.W. P.O. BOX 6117 Rochester, MN 55903 -6117 |
| Contact | Joan A Goetz |
| Correspondent | Joan A Goetz WATERS INSTRUMENTS, INC. 2411 SEVENTH ST. N.W. P.O. BOX 6117 Rochester, MN 55903 -6117 |
| Product Code | BZC |
| CFR Regulation Number | 868.1880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-09 |
| Decision Date | 1985-11-14 |