RECOVER INFANT HEEL WARMER (5100)— 510(k) K964523
Substantially EquivalentFlorida Medical Industries, Inc.
FDA 510(k) clearance K964523 for RECOVER INFANT HEEL WARMER (5100), Substantially Equivalent on 1997-02-10. Applicant: Florida Medical Industries, Inc.. Device class: 1.
Clearance details
- Applicant
- Florida Medical Industries, Inc.
- Product code
- Code MPO
- Device class
- Class 1
- Regulation
- 21 CFR 890.5710
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarpon Springs, FL, US
Recent devices under product code MPO
view allMore clearances from Florida Medical Industries, Inc.
view allRecalls naming K964523
K-number listed on FDA's recall record- Z-2094-2021 — Infant Heel Warmer with Attachment Tab, Nonsterile, Active Product SKU MH00002T The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside the pouch causing an exothermic chemical reaction, warming the pouch, which is then applied to the heel of an infant to aid in blood draws
- Z-2095-2021 — Infant Heel Warmer without Attachment Tab, Nonsterile, Active Product SKU MH00002N The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside the pouch causing an exothermic chemical reaction, warming the pouch, which is then applied to the heel of an infant to aid in blood draws
- Z-2443-2015 — Covidien Argyle Infant Heel Warmers (no tab) Item Code: MH00002N Product Usage: Intended for application of the right amount of heat to an infants heel for blood sampling
- Z-2444-2015 — Covidien Argyle Infant Heel Warmers (with tab) Item Code: MH00002T Product Usage: Intended for application of the right amount of heat to an infants heel for blood sampling.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K964523.
Data sourced from openFDA. This site is unofficial and independent of the FDA.