The following data is part of a premarket notification filed by Viasys Healthcare Gmbh with the FDA for Spiropro Spo2.
| Device ID | K031515 |
| 510k Number | K031515 |
| Device Name: | SPIROPRO SPO2 |
| Classification | Oximeter |
| Applicant | VIASYS HEALTHCARE GMBH 22705 SAVI RANCH PKWY. Yorba Linda, CA 92887 |
| Contact | Earl Draper |
| Correspondent | Earl Draper VIASYS HEALTHCARE GMBH 22705 SAVI RANCH PKWY. Yorba Linda, CA 92887 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-14 |
| Decision Date | 2003-11-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04057155000382 | K031515 | 000 |