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 |