Adult Cerebral-Somatic Oximetry Sensor, Pediatric Cerebral-Somatic Oximetry Sensor Model Hhs-Safb-Sm, Hhs-Spfb-Usa
FDA 510(k) K100523 · Hygia Health Services, Inc.
510(k) numberK100523
Submission
- Device name
- Adult Cerebral-Somatic Oximetry Sensor, Pediatric Cerebral-Somatic Oximetry Sensor Model Hhs-Safb-Sm, Hhs-Spfb-Usa
- Applicant
- Hygia Health Services, Inc.
Birmingham, AL, US - Received
- February 24, 2010
- Decision date
- May 4, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NMD – Oximeter, Tissue Saturation, Reprocessed
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2700
- Specialty
- Cardiovascular
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).
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| K111007 | Midwest Reprocessing Center Reprocessed LNCS Sessors; Midwest Reprocessing Center…NMD · Traditional | Midwest Reprocessing Center, LLC | 06/08/2011SE |
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Questions and answers
When was Adult Cerebral-Somatic Oximetry Sensor, Pediatric Cerebral-Somatic Oximetry Sensor Model Hhs-Safb-Sm, Hhs-Spfb-Usa cleared by the FDA?
Adult Cerebral-Somatic Oximetry Sensor, Pediatric Cerebral-Somatic Oximetry Sensor Model Hhs-Safb-Sm, Hhs-Spfb-Usa (K100523) received a 510(k) decision of Substantially Equivalent on May 4, 2010, 69 days after the submission was received.
What is the product code of K100523?
The FDA product code is NMD – Oximeter, Tissue Saturation, Reprocessed, a Class II (moderate risk) device regulated under 21 CFR 870.2700.