FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
BATCH #6060 CONDUCTIVE GEL
K Number: K983964
·
Decision Dec 9, 1998
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
68
Applicant Total
20
Review Days
33
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
- BATCH #6060 CONDUCTIVE GEL
- K Number
- K983964
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1275
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Skylark Device Co., Ltd.
- Date Received
- November 6, 1998
- Decision Date
- December 9, 1998
- Product Code
- GYB
- 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 |
|---|---|---|---|
| GYB | Media, Electroconductive | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GYB), ordered by most recent decision date.
Jmoon Conductive Gel
FDA 510(k)
FDA Class 2
·Neurology
Avologi Gel Primer (Model: Av25)
FDA 510(k)
FDA Class 2
·Neurology
Conductive Gel
FDA 510(k)
FDA Class 2
·Neurology
Conductive Gel
FDA 510(k)
FDA Class 2
·Neurology
EEG-acp
FDA 510(k)
FDA Class 2
·Neurology
AC Cream - Conductive paste
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Skylark Device Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K990233 | ST-302 INFRAREX | Oct 27, 1999 | Substantially Equivalent |
| K984506 | SD-100 SKYEAR THERMOMETER | Jul 29, 1999 | Substantially Equivalent |
| K981449 | SD-956 ULTRASOUND THERAPY | Dec 11, 1998 | Substantially Equivalent |
| K964437 | GB-1002 TENS WITH MASSAGE | Aug 14, 1998 | Substantially Equivalent |
| K974585 | IF-727 INTERFERENTIAL STIMULATOR | Mar 6, 1998 | Substantially Equivalent |
| K964434 | SD-970EMS ELECTRICAL MUSCULAR STIMULATOR | Oct 9, 1997 | Substantially Equivalent |
| K963729 | SD-610M(ALSO KNOWN AS STANDARD TENS, SD-609M,SD-611M, GLC-I STANDARD) | Feb 13, 1997 | Substantially Equivalent |
| K946337 | IT-727 (ALSO KNOWN AS IT-610, IT-600 AND DYNAPHOR II | Dec 20, 1995 | Substantially Equivalent |
| K946299 | PGS123 AND HVS-123 | Jun 26, 1995 | Substantially Equivalent |
| K934051 | BIO SDP (AKA SATURN SD, GLC-III SD & STAT-SD) | Jul 11, 1994 | Substantially Equivalent |