MODIFICATION TO ANIMEC, MODELS AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5
FDA 510(k) clearance K024373 · decided 2003-01-28
Clearance details
- K-number
- K024373
- Device name
- MODIFICATION TO ANIMEC, MODELS AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5
- Applicant
- Elltec Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2002-12-31
- Decision date
- 2003-01-28
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- LGZ
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Nagoya, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.