HYGIA HEALTH SERVICES REPROCESSED BLOOD PRESSURE CUFF

Reprocessed Blood Pressure Cuff

HYGIA HEALTH SERVICES, INC.

The following data is part of a premarket notification filed by Hygia Health Services, Inc. with the FDA for Hygia Health Services Reprocessed Blood Pressure Cuff.

Pre-market Notification Details

• Device ID: K032821
• 510k Number: K032821
• Device Name: HYGIA HEALTH SERVICES REPROCESSED BLOOD PRESSURE CUFF
• Classification: Reprocessed Blood Pressure Cuff
• Applicant: HYGIA HEALTH SERVICES, INC. 434 INDUSTRIAL LN. Birmingham, AL 35211
• Contact: Tracy W Comas
• Correspondent: Tracy W Comas; HYGIA HEALTH SERVICES, INC. 434 INDUSTRIAL LN. Birmingham, AL 35211
• Product Code: NPP
• CFR Regulation Number: 870.1120 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-09-05
• Decision Date: 2003-12-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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