The following data is part of a premarket notification filed by Aristo Medical Products, Inc. with the FDA for Sdi Oxygen/digital Oxygen Transducers (dot).
| Device ID | K920966 |
| 510k Number | K920966 |
| Device Name: | SDI OXYGEN/DIGITAL OXYGEN TRANSDUCERS (DOT) |
| Classification | Oximeter |
| Applicant | ARISTO MEDICAL PRODUCTS, INC. 21850 WATERTOWN ROAD, BUILDING D Waukesha, WI 53186 |
| Contact | David A Lovejoy |
| Correspondent | David A Lovejoy ARISTO MEDICAL PRODUCTS, INC. 21850 WATERTOWN ROAD, BUILDING D Waukesha, WI 53186 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-02 |
| Decision Date | 1993-07-16 |