The following data is part of a premarket notification filed by Aristo Medical Products, Inc. with the FDA for Aristo Medical Model 2101 Patient Monitor.
| Device ID | K953817 |
| 510k Number | K953817 |
| Device Name: | ARISTO MEDICAL MODEL 2101 PATIENT MONITOR |
| Classification | Oximeter |
| Applicant | ARISTO MEDICAL PRODUCTS, INC. P.O. BOX 1637 Waukesha, WI 53187 -2345 |
| Contact | Stephen H Gorski |
| Correspondent | Stephen H Gorski ARISTO MEDICAL PRODUCTS, INC. P.O. BOX 1637 Waukesha, WI 53187 -2345 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-14 |
| Decision Date | 1995-11-22 |