The following data is part of a premarket notification filed by Olympic Medical Corp. with the FDA for Olympic Smart Scale.
Device ID | K955177 |
510k Number | K955177 |
Device Name: | OLYMPIC SMART SCALE |
Classification | Scale, Patient |
Applicant | OLYMPIC MEDICAL CORP. 5900 FIRST AVE., SOUTH Seattle, WA 98108 |
Contact | Joseph P Stefanile |
Correspondent | Joseph P Stefanile OLYMPIC MEDICAL CORP. 5900 FIRST AVE., SOUTH Seattle, WA 98108 |
Product Code | FRW |
CFR Regulation Number | 880.2720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-11-13 |
Decision Date | 1995-12-14 |