FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROGEL(TM), MODELS 8630 AND 8635
K Number: K882887
·
Decision Sep 29, 1988
Classifications
1
FEI Numbers
242
Registration Numbers
242
Same Product Code
426
Applicant Total
49
Review Days
80
Basic Information
- Device Name
- PROGEL(TM), MODELS 8630 AND 8635
- K Number
- K882887
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1320
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- MEDICAL DEVICES, INC.
- Date Received
- July 11, 1988
- Decision Date
- September 29, 1988
- Product Code
- GXY
- 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 |
|---|---|---|---|
| GXY | Electrode, Cutaneous | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GXY), ordered by most recent decision date.
IceCap product line
FDA 510(k)
FDA Class 2
·Neurology
Delphi MCS Electrode Cap
FDA 510(k)
FDA Class 2
·Neurology
Electrode Pad
FDA 510(k)
FDA Class 2
·Neurology
Wave Electrode (AE02-60); Wave Electrode (AE02-50)
FDA 510(k)
FDA Class 2
·Neurology
CAIs Sensor (CAIs-001)
FDA 510(k)
FDA Class 2
·Neurology
WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281)
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by MEDICAL DEVICES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K002280 | PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602 | Feb 5, 2001 | Substantially Equivalent |
| K930084 | MICRO-ARTHROSCOPE | Sep 1, 1995 | Substantially Equivalent for Some Indications |
| K940012 | SMARTBRACE ELECTRODE | Dec 5, 1994 | Substantially Equivalent |
| K943126 | ELECTROFLEX | Dec 5, 1994 | Substantially Equivalent |
| K935132 | HOME MICROCURRENT HMC | Mar 14, 1994 | Substantially Equivalent |
| K934619 | FLEXMATE | Feb 23, 1994 | Substantially Equivalent |
| K924897 | XENON ENDOSCOPIC ILLUMINATOR, MODEL XEI-300 | Jul 6, 1993 | Substantially Equivalent |
| K930053 | VIDEO CAMERA W/ ELECTRONIC SHUTTER MODEL VCE-10 | May 17, 1993 | Substantially Equivalent |
| K923914 | IF-II (TM), MODEL 7200 | Nov 6, 1992 | Substantially Equivalent |
| K920071 | MEDITRON AUTOMATIC ELECTRONIC INSUFF. MODEL AEI-15 | Jul 21, 1992 | Substantially Equivalent |