FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYGIA HEALTH SERVICES REPROCESSED NOVAMEDIX IMPAB MODELS 5065, 5075, 5087, 5089
K Number: K021509
·
Decision Dec 24, 2002
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
349
Applicant Total
14
Review Days
229
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Basic Information
- Device Name
- HYGIA HEALTH SERVICES REPROCESSED NOVAMEDIX IMPAB MODELS 5065, 5075, 5087, 5089
- K Number
- K021509
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 870.5800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hygia Health Services, Inc.
- Date Received
- May 9, 2002
- Decision Date
- December 24, 2002
- Product Code
- JOW
- 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 |
|---|---|---|---|
| JOW | Sleeve, Limb, Compressible | FDA class 2 | Cardiovascular |
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Other Clearances by Hygia Health Services, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K100523 | ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENSOR MODEL HHS-SAFB-SM, HHS-SPFB-USA | May 4, 2010 | Substantially Equivalent |
| 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 |
| 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 |