ALLEGIANCE PORTA-WARM MATTRESS— 510(k) K982652
Substantially EquivalentAllegiance Healthcare Corp.
FDA 510(k) clearance K982652 for ALLEGIANCE PORTA-WARM MATTRESS, Substantially Equivalent on 1999-01-21. Applicant: Allegiance Healthcare Corp.. Device class: 1.
Clearance details
- Applicant
- Allegiance Healthcare Corp.
- Product code
- Code IMD
- Device class
- Class 1
- Regulation
- 21 CFR 890.5710
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mcgraw Park, IL, US
Recent devices under product code IMD
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- K024120 — MODIFICATION TO TEMNO BIOPSY NEEDLES
- K024292 — MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN AND CHEMOTHERAPY LABELING CLAIM
- K024102 — DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
Adverse events under product code IMD
product code IMD- Death
- 3
- Injury
- 600
- Total
- 603
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.