MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L
FDA 510(k) clearance K993568 · decided 2000-03-13
Clearance details
- K-number
- K993568
- Device name
- MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L
- Applicant
- Machida Endoscope Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1999-10-21
- Decision date
- 2000-03-13
- Days to decision
- 144 days
- Clearance type
- Traditional
- Product code
- GWG
- Device class
- 2
- Regulation number
- 882.1480
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Tokyo, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.