The following data is part of a premarket notification filed by Solaris Medical Technology, Inc. with the FDA for Solaris Nt1 And Nt1a Handheld Pulse Oximeters With Sensor Accessories.
| Device ID | K073249 |
| 510k Number | K073249 |
| Device Name: | SOLARIS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES |
| Classification | Oximeter |
| Applicant | SOLARIS MEDICAL TECHNOLOGY, INC. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Contact | Alan Schwartz |
| Correspondent | Alan Schwartz SOLARIS MEDICAL TECHNOLOGY, INC. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-19 |
| Decision Date | 2008-07-25 |
| Summary: | summary |