The following data is part of a premarket notification filed by Advanced Vascular Dynamics with the FDA for Flochec Photo Plethysmographic Device.
| Device ID | K093192 |
| 510k Number | K093192 |
| Device Name: | FLOCHEC PHOTO PLETHYSMOGRAPHIC DEVICE |
| Classification | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
| Applicant | ADVANCED VASCULAR DYNAMICS 1910 NW 23RD PLACE Portland, OR 97210 |
| Contact | Herbert Semler |
| Correspondent | Herbert Semler ADVANCED VASCULAR DYNAMICS 1910 NW 23RD PLACE Portland, OR 97210 |
| Product Code | JOM |
| CFR Regulation Number | 870.2780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-09 |
| Decision Date | 2010-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859433006055 | K093192 | 000 |
| 00859433006031 | K093192 | 000 |
| 00859433006000 | K093192 | 000 |