FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SIGNAPAD
K Number: K780973
·
Decision Jul 27, 1978
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
68
Applicant Total
30
Review Days
45
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
- SIGNAPAD
- K Number
- K780973
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1275
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Parker Laboratories, Inc.
- Date Received
- June 12, 1978
- Decision Date
- July 27, 1978
- 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 Parker Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K233965 | UltraDrape UGPIV Barrier and Securement (34-15) | Aug 15, 2024 | Substantially Equivalent |
| K953673 | ECLIPSE PROBE COVER | Mar 14, 1996 | Substantially Equivalent |
| K921695 | ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERS | Feb 23, 1995 | Substantially Equivalent |
| K864556 | AQUALUBE(TM) | Dec 1, 1986 | Substantially Equivalent |
| K861239 | ACRYLIC SOLDER | Apr 17, 1986 | Substantially Equivalent |
| K855167 | DYNA SYSTEM | Mar 4, 1986 | Substantially Equivalent |
| K851895 | POLYGEL ULTRASOUND GEL | Sep 27, 1985 | Substantially Equivalent |
| K852956 | CONTACT CONDUCTIVE ADHESIVE GEL COMPOSITION | Aug 9, 1985 | Substantially Equivalent |
| K841400 | NEURO PULSE | Jun 15, 1984 | Substantially Equivalent |
| K840548 | RESIL | Apr 17, 1984 | Substantially Equivalent |