Disposable Laryngeal Electrodes
FDA 510(k) clearance K232888 · decided 2023-12-21
Clearance details
- K-number
- K232888
- Device name
- Disposable Laryngeal Electrodes
- Applicant
- Suzhou Haishen Medical Device Associates Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-09-18
- Decision date
- 2023-12-21
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- ETN
- Device class
- 2
- Regulation number
- 874.1820
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Suzhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.