HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II— 510(k) K012715

Clearance details

Applicant

Hygia Health Services, Inc.

Product code

Code NLF

Device class

Class 2

Regulation

21 CFR 870.2700

Advisory panel

Cardiovascular

Date received

2001-08-14

Decision date

2003-08-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Birmingham, AL, US

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