The following data is part of a premarket notification filed by Waters Instruments, Inc. with the FDA for Oxicom-2100.
| Device ID | K921519 |
| 510k Number | K921519 |
| Device Name: | OXICOM-2100 |
| Classification | Oximeter |
| Applicant | WATERS INSTRUMENTS, INC. 2411 SEVENTH ST. N.W. P.O. BOX 6117 Rochester, MN 55903 -6117 |
| Contact | Steve Boutelle |
| Correspondent | Steve Boutelle WATERS INSTRUMENTS, INC. 2411 SEVENTH ST. N.W. P.O. BOX 6117 Rochester, MN 55903 -6117 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-31 |
| Decision Date | 1992-10-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B154OXIKIT21003 | K921519 | 000 |
| B154O00072900000 | K921519 | 000 |