510(k) K032821
- Device
- HYGIA HEALTH SERVICES REPROCESSED BLOOD PRESSURE CUFF
- Applicant
- HYGIA HEALTH SERVICES, INC.
- 510(k) number
- K032821
- Product code
- NPP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-12-05
- Date received
- 2003-09-05
- Regulation
- 870.1120
- Classification name
- Reprocessed 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
- TRACY W COMAS
- Address
- 434 Industrial Ln. Birmingham AL US 35211 35211
FDA Registration Numbers#
- 1018470
- 3016904853
Source Documents#
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases