The following data is part of a premarket notification filed by New Tech, Inc. with the FDA for Nt1d Vital Signs Monitor.
| Device ID | K123797 |
| 510k Number | K123797 |
| Device Name: | NT1D VITAL SIGNS MONITOR |
| Classification | Oximeter |
| Applicant | NEW TECH, INC. P.O. BOX 237-023 Shanghai, CN 200237 |
| Contact | Diana Hong |
| Correspondent | Diana Hong NEW TECH, INC. P.O. BOX 237-023 Shanghai, CN 200237 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-10 |
| Decision Date | 2013-08-27 |
| Summary: | summary |