510(k) K905207— MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS
Substantially Equivalent for Some IndicationsMicro Surgical Instruments Corp.
Clearance details
- Applicant
- Micro Surgical Instruments Corp.
- Product code
- Code IME
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Valencia, CA, US
Adverse events under product code IME
product code IME- 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.