510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K100523Substantially Equivalent

Adult Cerebral-Somatic Oximetry Sensor, Pediatric Cerebral-Somatic Oximetry Sensor Model Hhs-Safb-Sm, Hhs-Spfb-USA

Hygia Health Services, Inc., Birmingham AL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100523 is the FDA 510(k) clearance record for ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENSOR MODEL HHS-SAFB-SM, HHS-SPFB-USA, a class II device, cleared for Hygia Health Services, Inc. on under FDA product code NMD (Oximeter, Tissue Saturation, Reprocessed). FDA's definition for product code NMD reads: "Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)". FDA records list 14 510(k) clearances for Hygia Health Services, Inc., from to . As of , FDA records show no recalls naming K100523.

Clearance record

Decision date
Received
(69 days to decision)
Product code
NMD Oximeter, Tissue Saturation, Reprocessed
Regulation
21 CFR 870.2700
Device class
Class II
Review panel
Cardiovascular
Applicant
Hygia Health Services, Inc. 434 Industrial Ln., Birmingham AL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NMD

Trailing 12 months

FDA records hold no clearances under product code NMD in the trailing twelve months.

FDA records show no clearances under product code NMD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NMD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260