FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENSOR MODEL HHS-SAFB-SM, HHS-SPFB-USA
K Number: K100523
·
Decision May 4, 2010
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
1
Applicant Total
14
Review Days
69
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Basic Information
- Device Name
- ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENSOR MODEL HHS-SAFB-SM, HHS-SPFB-USA
- K Number
- K100523
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hygia Health Services, Inc.
- Date Received
- February 24, 2010
- Decision Date
- May 4, 2010
- Product Code
- NMD
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NMD | Oximeter, Tissue Saturation, Reprocessed | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NMD), ordered by most recent decision date.
View allOther Clearances by Hygia Health Services, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K090074 | HYGIA HEALTH SERVICES REPROCESSED COMPRESSION SLEEVES / FOOT CUFFS | Apr 22, 2009 | Substantially Equivalent |
| K080424 | HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862, HHS-1860 AND HHS-1861 | May 28, 2008 | Substantially Equivalent |
| K053575 | HYGIA HEALTH SERVICES REPROCESSED KENDALL SCD EXPRESS SLEEVES/FOOT CUFFS | Feb 15, 2006 | Substantially Equivalent |
| K041867 | HYGIA HEALTH SERVICES REPROCESSED OXIMAX SENSORS MODEL # HHS-MAX-A, HHS-MAX-AL, HHS-MAX-N | Sep 10, 2004 | Substantially Equivalent |
| K032821 | HYGIA HEALTH SERVICES REPROCESSED BLOOD PRESSURE CUFF | Dec 5, 2003 | Substantially Equivalent |
| K012715 | HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II | Aug 1, 2003 | Substantially Equivalent |
| K021509 | HYGIA HEALTH SERVICES REPROCESSED NOVAMEDIX IMPAB MODELS 5065, 5075, 5087, 5089 | Dec 24, 2002 | Substantially Equivalent |
| K012650 | HYGIA HEALTH SERVICES REPROCESSED NUTECH FOOT WRAP | Apr 12, 2002 | Substantially Equivalent |
| K012654 | HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FLOWTRON DVT SLEEVE MODELS DVT10, DVT 20, DVT 30, DVT 40 | Apr 12, 2002 | Substantially Equivalent |
| K012657 | HYGIA HEALTH SERVICES REPROCESSED NUTECH CALF WRAP | Apr 12, 2002 | Substantially Equivalent |