510(k) K833172
- Device
- ECG-GEL ELECTRODE GEL
- Applicant
- Whs Products, Inc.
- 510(k) number
- K833172
- Product code
- GYB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-11-21
- Date received
- 1983-09-16
- Regulation
- 882.1275
- Classification name
- Media, Electroconductive
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3011721071
- 1626185
- 1718791
- 1055808
- 1017294
- 2245302
- 3031757047
- 3031841433
- 1000524645
- 3010097863
- 3006626283
- 3027329006
- 3014236293
- 3031464228
- 3010836847
- 3012386142
- 9710580
- 9611558
- 3013957847
- 3028011
- 3006551156
- 3045752480
- 8030229
- 9611252
- 1650946
- 3013917867
- 3017953405
- 3006315274
- 3006258337
- 3042272797
- 3028172072
- 9613619
- 3011077581
- 3011310592
- 3012494290
- 3013501110
- 3006459199
- 3011534533
- 3008085016
- 3016852448
- 3036720861
- 1000150986
- 1528161
- 3023339103
- 3006982887
- 3001236514
- 3010515191
- 2011115
- 3043013796
- 3042268484
- 2212018
- 3012316249
- 3003676119
- 3004146401
- 3007481893
- 1417592
- 3012134907
- 2080783
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GYB#
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| K161715 | EndyGel | Endymed Medical, Ltd. | 2017-02-07 |
| K161654 | NuFACE Gel Primer | Carol Cole Company | 2016-12-30 |
| K111717 | ELECTRO-GEL | Electro-Cap Intl., Inc. | 2012-01-05 |
| K032239 | THERA-CREAM, MODEL TCT004 | Prizm Medical, Inc. | 2004-07-30 |