510(k) K935260
- Device
- PHYSIOMETRIX CABLE ADAPTER MODIFICATION
- Applicant
- PHYSIOMETRIX, INC.
- 510(k) number
- K935260
- Product code
- IKD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-12-23
- Date received
- 1993-11-02
- Regulation
- 890.1175
- Classification name
- Cable, Electrode
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Claire Andrews
- Address
- 575 N. Pastoria Ave. Sunnyvale CA US 94086 94086
FDA Registration Numbers#
- 3013557562
- 3012804266
- 3013783488
- 2182269
- 1319639
- 2032112
- 1718873
- 3010280625
- 3011024991
- 3013426279
- 3013439886
- 1000121056
- 3008773647
- 3008812560
- 3009555600
- 9681377
- 9612330
- 3007307487
- 3034520
- 3049808762
- 3009437315
- 3005334138
- 3004753827
- 3001570235
- 2031966
- 9710602
- 3020018
- 2032273
- 3021691064
- 3004035727
- 3031887985
- 2953359
- 3017206625
- 3015910259
- 3017450375
- 3010200163
- 3004832480
- 1044143
- 2184149
- 3006850006
- 2242056
- 3005581270
- 3015286931
- 3043013796
- 3004753785
- 3044563261
- 2135338
- 3009241989
- 9616086
- 9610612
- 3016618143
- 3012316249
- 1417592
- 3011713222
- 9710051
- 3030498429
- 1018470
- 3012797688
- 3003418325
- 3008603863
- 3014341624
- 3007636029
- 3007048259
- 2183456
- 3010611950
- 3005170249
- 3008483389
- 3004839404
- 3003617581
- 3007389703
- 3014220748
- 3030125051
- 3016096099
- 1049754
- 3008892509
- 3006636961
- 1721983
- 3006552505
- 3011310592
- 3010402752
Source Documents#
Other 510(k) Records For Product Code IKD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K070926 | ELECTRODE/EXTENSION CABLES, MODELS ATAR | Oscor, Inc. | 2007-06-07 |
| K992372 | THE LEADAWAY | Therapy Equipment, Inc. | 1999-10-13 |
| K873361 | LIFE-SPAN CABLE | Chemfet Corp. | 1987-11-09 |
| K834583 | CLEAR LEADS-RADIOTRANSPARENT WIRES | Quinton, Inc. | 1984-01-30 |
| K800934 | R2 ESU CABLE-ADAPTER MODELS 160,161 | R2 Corp. | 1980-05-20 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases