The following data is part of a premarket notification filed by Imagyn Medical Technologies, Inc. with the FDA for Im2001 Pulse Oximeter.
| Device ID | K012706 |
| 510k Number | K012706 |
| Device Name: | IM2001 PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | IMAGYN MEDICAL TECHNOLOGIES, INC. 1730 PENNSYLVANIA AVE., NW Washington, DC 20006 |
| Contact | Sandra Cohen Kalter |
| Correspondent | Sandra Cohen Kalter IMAGYN MEDICAL TECHNOLOGIES, INC. 1730 PENNSYLVANIA AVE., NW Washington, DC 20006 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-14 |
| Decision Date | 2003-03-07 |
| Summary: | summary |