HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FLOWTRON DVT SLEEVE MODELS DVT10, DVT 20, DVT 30, DVT 40— 510(k) K012654
Substantially EquivalentHygia Health Services, Inc.
FDA 510(k) clearance K012654 for HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FLOWTRON DVT SLEEVE MODELS DVT10, DVT 20, DVT 30, DVT 40, Substantially Equivalent on 2002-04-12. Applicant: Hygia Health Services, Inc.. Device class: 2.
Clearance details
- Applicant
- Hygia Health Services, Inc.
- Product code
- Code JOW
- Device class
- Class 2
- Regulation
- 21 CFR 870.5800
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Birmingham, AL, US
Recent devices under product code JOW
view allMore clearances from Hygia Health Services, Inc.
view all- K100523 — ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENSOR MODEL HHS-SAFB-SM, HHS-SPFB-USA
- K090074 — HYGIA HEALTH SERVICES REPROCESSED COMPRESSION SLEEVES / FOOT CUFFS
- K080424 — HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862, HHS-1860 AND HHS-1861
- K053575 — HYGIA HEALTH SERVICES REPROCESSED KENDALL SCD EXPRESS SLEEVES/FOOT CUFFS
- K041867 — HYGIA HEALTH SERVICES REPROCESSED OXIMAX SENSORS MODEL # HHS-MAX-A, HHS-MAX-AL, HHS-MAX-N
Data sourced from openFDA. This site is unofficial and independent of the FDA.