ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R
FDA 510(k) clearance K200968 · decided 2020-12-28
Clearance details
- K-number
- K200968
- Device name
- ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R
- Applicant
- Insung Medical Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2020-04-10
- Decision date
- 2020-12-28
- Days to decision
- 262 days
- Clearance type
- Traditional
- Product code
- CBI
- Device class
- 2
- Regulation number
- 868.5740
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Gangwon-Do, KR
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.