ACROTHERM
FDA 510(k) clearance K003368 · decided 2001-01-19
Clearance details
- K-number
- K003368
- Device name
- ACROTHERM
- Applicant
- Aquarius Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2000-10-30
- Decision date
- 2001-01-19
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- DWJ
- Device class
- 2
- Regulation number
- 870.5900
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Scottsdale, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.