DRTS REMOTE CONTROL DRAPE— 510(k) K973067
Substantially EquivalentMinrad, Inc.
FDA 510(k) clearance K973067 for DRTS REMOTE CONTROL DRAPE, Substantially Equivalent on 1997-10-16. Applicant: Minrad, Inc.. Device class: 2.
Clearance details
- Applicant
- Minrad, Inc.
- Product code
- Code JAA
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Orchard Park, NY, US
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Adverse events under product code JAA
product code JAA- Other
- 1
- Total
- 1
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.