The following data is part of a premarket notification filed by Smiths Medical Pm, Inc. with the FDA for Bci Ww1020 Pulse Oximeter, Model Ww1020.
| Device ID | K083705 |
| 510k Number | K083705 |
| Device Name: | BCI WW1020 PULSE OXIMETER, MODEL WW1020 |
| 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 | 2008-12-15 |
| Decision Date | 2009-04-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30843418001204 | K083705 | 000 |
| 30843418000818 | K083705 | 000 |
| 30843418000801 | K083705 | 000 |
| 30843418000757 | K083705 | 000 |
| 30843418000375 | K083705 | 000 |
| 30843418000108 | K083705 | 000 |