DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS— 510(k) K980509
Substantially EquivalentDeroyal Industries, Inc.
FDA 510(k) clearance K980509 for DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS, Substantially Equivalent on 1998-02-26. Applicant: Deroyal Industries, Inc.. Device class: 1.
Clearance details
- Applicant
- Deroyal Industries, Inc.
- 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
- Powell, TN, US
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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.