Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series
FDA 510(k) clearance K201949 · decided 2021-05-02
Clearance details
- K-number
- K201949
- Device name
- Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series
- Applicant
- Nihon Kohden Corporation
- Decision
- Substantially Equivalent
- Date received
- 2020-07-13
- Decision date
- 2021-05-02
- Days to decision
- 293 days
- Clearance type
- Traditional
- Product code
- KOI
- Device class
- 2
- Regulation number
- 868.2775
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- 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.