510(k) K122365
- Device
- ULTRACHECK CURVE BLOOD PRESSURE CUFFS
- Applicant
- STATCORP MEDICAL
- 510(k) number
- K122365
- Product code
- OED
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-06-04
- Date received
- 2012-08-06
- Regulation
- 870.1120
- Classification name
- Antimicrobial Blood Pressure Cuff
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- WAYNE EMMERT
- Address
- 14476 Duval Pl. W. Suite 303 Jacksonville FL US 32218 32218
FDA Registration Numbers#
- 3010157426
- 3000126629
- 1218950
- 3016618143
- 9610816
- 1222630
- 3004727093
- 3014541700
Source Documents#
Other 510(k) Records For Product Code OED #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K071885 | ANTIMICROBIAL AND SINGLE-PATIENT CUFFS | Philips Medical Systems | 2007-12-20 |
Legacy Summary#
summary
FDA Review#
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