FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EARPROBE
K Number: K100661
·
Decision Jul 1, 2010
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
75
Applicant Total
6
Review Days
115
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- EARPROBE
- K Number
- K100661
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1900
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Path Medical GmbH
- Date Received
- March 8, 2010
- Decision Date
- July 1, 2010
- Product Code
- GWJ
- Advisory Committee
- Neurology
- 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 |
|---|---|---|---|
| GWJ | Stimulator, Auditory, Evoked Response | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GWJ), ordered by most recent decision date.
Integrity V500 (Integrity, Integrity with VEMP)
FDA 510(k)
FDA Class 2
·Neurology
ALGO Pro Newborn Hearing Screener (ALGO Pro)
FDA 510(k)
FDA Class 2
·Neurology
QScreen
FDA 510(k)
FDA Class 2
·Neurology
ALGO 7i
FDA 510(k)
FDA Class 2
·Neurology
GSI Audera Pro
FDA 510(k)
FDA Class 2
·Neurology
SmartEP
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Path Medical GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K220139 | QScreen | Aug 3, 2022 | Substantially Equivalent |
| K213345 | Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE | Jun 22, 2022 | Substantially Equivalent |
| K211147 | ALGO 7i | Oct 14, 2021 | Substantially Equivalent |
| K133012 | SENTIERO | Jun 9, 2014 | Substantially Equivalent |
| K131141 | EARPROBE | Jun 27, 2013 | Substantially Equivalent |