The following data is part of a premarket notification filed by Waters Instruments, Inc. with the FDA for Velcom-100.
| Device ID | K863210 |
| 510k Number | K863210 |
| Device Name: | VELCOM-100 |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | WATERS INSTRUMENTS, INC. 2411 SEVENTH ST. N.W. P.O. BOX 6117 Rochester, MN 55903 -6117 |
| Contact | Lewis N Harrold |
| Correspondent | Lewis N Harrold WATERS INSTRUMENTS, INC. 2411 SEVENTH ST. N.W. P.O. BOX 6117 Rochester, MN 55903 -6117 |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-20 |
| Decision Date | 1986-11-26 |