The following data is part of a premarket notification filed by Statcorp Medical with the FDA for Ultracheck Curve Blood Pressure Cuffs.
Device ID | K122365 |
510k Number | K122365 |
Device Name: | ULTRACHECK CURVE BLOOD PRESSURE CUFFS |
Classification | Antimicrobial Blood Pressure Cuff |
Applicant | STATCORP MEDICAL 14476 Duval Pl W Ste 303 Jacksonville, FL 32218 |
Contact | Wayne Emmert |
Correspondent | Wayne Emmert STATCORP MEDICAL 14476 Duval Pl W Ste 303 Jacksonville, FL 32218 |
Product Code | OED |
CFR Regulation Number | 870.1120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-08-06 |
Decision Date | 2013-06-04 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10841522106835 | K122365 | 000 |
10841522106880 | K122365 | 000 |
10841522106866 | K122365 | 000 |