The following data is part of a premarket notification filed by Shenzhen Envisen Industry Co. Limited with the FDA for Envisen Nellcor, Bci, Nonin, Csi, Hp/philips, Datex-ohmeda Compatible Disposable And Reusable Spo2 Sensors.
| Device ID | K103584 |
| 510k Number | K103584 |
| Device Name: | ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS |
| Classification | Oximeter |
| Applicant | SHENZHEN ENVISEN INDUSTRY CO. LIMITED S65 W35739 PIPER ROAD Eagle, WI 53119 |
| Contact | Stephen H Gorski |
| Correspondent | Stephen H Gorski SHENZHEN ENVISEN INDUSTRY CO. LIMITED S65 W35739 PIPER ROAD Eagle, WI 53119 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-07 |
| Decision Date | 2011-06-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10817698020329 | K103584 | 000 |
| 10817698020251 | K103584 | 000 |
| 10817698020244 | K103584 | 000 |
| 10817698020237 | K103584 | 000 |
| 10817698020213 | K103584 | 000 |
| 10817698020206 | K103584 | 000 |
| 10817698020190 | K103584 | 000 |