SI CONTROLLER MODEL SI 500— 510(k) K960492
Substantially EquivalentI.C Medical, Inc.
FDA 510(k) clearance K960492 for SI CONTROLLER MODEL SI 500, Substantially Equivalent on 1996-12-23. Applicant: I.C Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- I.C Medical, Inc.
- Product code
- Code BTA
- Device class
- Class 2
- Regulation
- 21 CFR 878.4780
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Glendale, AZ, US
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More clearances from I.C Medical, Inc.
view allAdverse events under product code BTA
product code BTA- Death
- 5
- Total
- 5
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.