ASTOTHERM IFT 250, IFT 260, ASTOTUBE VARIOUS NO.
FDA 510(k) clearance K914364 · decided 1992-09-10
Clearance details
- K-number
- K914364
- Device name
- ASTOTHERM IFT 250, IFT 260, ASTOTUBE VARIOUS NO.
- Applicant
- North American Technical Services Corp.
- Decision
- Substantially Equivalent
- Date received
- 1991-10-01
- Decision date
- 1992-09-10
- Days to decision
- 345 days
- Clearance type
- Traditional
- Product code
- LGZ
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Port Jefferson, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.