HYGIA HEALTH SERVICES REPROCESSED OXIMAX SENSORS MODEL # HHS-MAX-A, HHS-MAX-AL, HHS-MAX-N

Oximeter, Reprocessed

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 Oximax Sensors Model # Hhs-max-a, Hhs-max-al, Hhs-max-n.

Pre-market Notification Details

• Device ID: K041867
• 510k Number: K041867
• Device Name: HYGIA HEALTH SERVICES REPROCESSED OXIMAX SENSORS MODEL # HHS-MAX-A, HHS-MAX-AL, HHS-MAX-N
• Classification: Oximeter, Reprocessed
• Applicant: HYGIA HEALTH SERVICES, INC. 434 INDUSTRIAL LN. Birmingham, AL 35211
• Contact: Tracy Wood Comas
• Correspondent: Tracy Wood Comas; HYGIA HEALTH SERVICES, INC. 434 INDUSTRIAL LN. Birmingham, AL 35211
• Product Code: NLF
• CFR Regulation Number: 870.2700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-07-09
• Decision Date: 2004-09-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30817357020343	K041867	000
30817357020299	K041867	000
30817357020145	K041867	000
30817357020022	K041867	000
30817357020015	K041867	000