FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ES2 Neuromonitoring Accessory Instruments
K Number: K171807
·
Decision Jul 18, 2017
Classifications
1
FEI Numbers
58
Registration Numbers
58
Same Product Code
34
Applicant Total
81
Review Days
29
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Basic Information
- Device Name
- ES2 Neuromonitoring Accessory Instruments
- K Number
- K171807
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 874.1820
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stryker Corporation
- Date Received
- June 19, 2017
- Decision Date
- July 18, 2017
- Product Code
- PDQ
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| PDQ | Neurosurgical Nerve Locator | FDA class 2 | Ear, Nose, Throat |
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