DISPOSABLE INFLATION GAUGE— 510(k) K902695
Substantially EquivalentCook Urological, Inc.
FDA 510(k) clearance K902695 for DISPOSABLE INFLATION GAUGE, Substantially Equivalent on 1990-12-03. Applicant: Cook Urological, Inc.. Device class: 2.
Clearance details
- Applicant
- Cook Urological, Inc.
- Product code
- Code MAV
- Device class
- Class 2
- Regulation
- 21 CFR 870.1650
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Spencer, IN, US
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More clearances from Cook Urological, Inc.
view allAdverse events under product code MAV
product code MAV- Malfunction
- 1,433
- Total
- 1,433
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.