FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Disposable Laryngeal Electrodes
K Number: K232888
·
Decision Dec 21, 2023
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
94
Applicant Total
2
Review Days
94
Basic Information
- Device Name
- Disposable Laryngeal Electrodes
- K Number
- K232888
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.1820
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Suzhou Haishen Medical Device Associates Co., Ltd
- Date Received
- September 18, 2023
- Decision Date
- December 21, 2023
- Product Code
- ETN
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ETN | Stimulator, Nerve | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ETN), ordered by most recent decision date.
ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Bioscope Neuromonitor Device
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
EARP Nerve Cuff Electrode
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
EARP Nerve Cuff Electrode
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Other Clearances by Suzhou Haishen Medical Device Associates Co., Ltd
| K Number | Device Name | ||
|---|---|---|---|
| K232581 | Medical Disposable Sterile Needle Electrode | Dec 4, 2023 | Substantially Equivalent |