BAXTER SODIUM ACETATE INFANT HEEL WARMER— 510(k) K961154
Substantially EquivalentBaxter Healthcare Corp
FDA 510(k) clearance K961154 for BAXTER SODIUM ACETATE INFANT HEEL WARMER, Substantially Equivalent on 1996-06-06. Applicant: Baxter Healthcare Corp. Device class: 1.
Clearance details
- Applicant
- Baxter Healthcare Corp
- 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
- Mcgaw Park, IL, US
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Recalls naming K961154
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K961154.
Data sourced from openFDA. This site is unofficial and independent of the FDA.