The following data is part of a premarket notification filed by Smiths Medical Pm, Inc. with the FDA for Bci Ww1030 Pulse Oximeter.
| Device ID | K083557 |
| 510k Number | K083557 |
| Device Name: | BCI WW1030 PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | SMITHS MEDICAL PM, INC. N7 W22025 JOHNSON DR. Waukesha, WI 53186 -1856 |
| Contact | Donald Alexander |
| Correspondent | Donald Alexander SMITHS MEDICAL PM, INC. N7 W22025 JOHNSON DR. Waukesha, WI 53186 -1856 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-02 |
| Decision Date | 2009-05-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30843418001211 | K083557 | 000 |
| 30843418000191 | K083557 | 000 |
| 10610586039645 | K083557 | 000 |
| 10610586039669 | K083557 | 000 |
| 10610586039652 | K083557 | 000 |