The following data is part of a premarket notification filed by General Meditech, Inc. with the FDA for G1b Pulse Oximeter.
| Device ID | K082789 |
| 510k Number | K082789 |
| Device Name: | G1B PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | GENERAL MEDITECH, INC. SUITE 8D, NO.19, LANE 999 ZHONGSHAN NO. 2 ROAD (S) Shanghai, CN 200030 |
| Contact | Diana Hong |
| Correspondent | Diana Hong GENERAL MEDITECH, INC. SUITE 8D, NO.19, LANE 999 ZHONGSHAN NO. 2 ROAD (S) 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 | 2008-09-23 |
| Decision Date | 2009-01-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06938368100039 | K082789 | 000 |
| 06938368100015 | K082789 | 000 |