The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for H100b Pulse Oximeter.
| Device ID | K092727 |
| 510k Number | K092727 |
| Device Name: | H100B PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | EDAN INSTRUMENTS, INC. SUITE 8D, NO.19, LANE 999 ZHONGSHAN ROAD (S-2) Shanghai, CN 200030 |
| Contact | Li Fu |
| Correspondent | Li Fu EDAN INSTRUMENTS, INC. SUITE 8D, NO.19, LANE 999 ZHONGSHAN ROAD (S-2) Shanghai, CN 200030 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-04 |
| Decision Date | 2009-12-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815871021074 | K092727 | 000 |
| 00815871021067 | K092727 | 000 |