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510(k) K100523

ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENSOR MODEL HHS-SAFB-SM, HHS-SPFB-USA by Hygia Health Services, Inc. — Product Code NMD

K100523 is an FDA 510(k) premarket notification submitted by Hygia Health Services, Inc. for the device "ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENSOR MODEL HHS-SAFB-SM, HHS-SPFB-USA". The FDA issued a decision of Substantially Equivalent on May 4, 2010. The device falls under product code NMD (Oximeter, Tissue Saturation, Reprocessed), a Class II device regulated under 21 CFR 870.2700. Hygia Health Services, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2010
Date Received
February 24, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter, Tissue Saturation, Reprocessed
Device Class
Class II
Regulation Number
870.2700
Review Panel
CV
Submission Type

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).

Other clearances by Hygia Health Services, Inc.

  • K090074 — HYGIA HEALTH SERVICES REPROCESSED COMPRESSION SLEEVES / FOOT CUFFS (April 22, 2009)
  • K080424 — HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862, HHS-1 (May 28, 2008)
  • K053575 — HYGIA HEALTH SERVICES REPROCESSED KENDALL SCD EXPRESS SLEEVES/FOOT CUFFS (February 15, 2006)
  • K041867 — HYGIA HEALTH SERVICES REPROCESSED OXIMAX SENSORS MODEL # HHS-MAX-A, HHS-MAX-AL, (September 10, 2004)
  • K032821 — HYGIA HEALTH SERVICES REPROCESSED BLOOD PRESSURE CUFF (December 5, 2003)
  • K012715 — HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II (August 1, 2003)
  • K021509 — HYGIA HEALTH SERVICES REPROCESSED NOVAMEDIX IMPAB MODELS 5065, 5075, 5087, 5089 (December 24, 2002)
  • K012657 — HYGIA HEALTH SERVICES REPROCESSED NUTECH CALF WRAP (April 12, 2002)
  • K012654 — HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FLOWTRON DVT SLEEVE MODELS DVT10, DV (April 12, 2002)
  • K012650 — HYGIA HEALTH SERVICES REPROCESSED NUTECH FOOT WRAP (April 12, 2002)

Other clearances for product code NMD

  • K111007 — MIDWEST REPROCESSING CENTER REPROCESSED LNCS SESSORS; MIDWEST REPROCESSING CENTE (June 8, 2011)

FDA data resources