Life-Span Cable
FDA 510(k) K873361 · Chemfet Corp.
510(k) numberK873361
Submission
- Device name
- Life-Span Cable
- Applicant
- Chemfet Corp.
Bellevue, WA, US - Received
- August 21, 1987
- Decision date
- November 9, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IKD – Cable, Electrode
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.1175
- Specialty
- Physical Medicine
Other 510(k)s with product code IKD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K070926 | Electrode/Extension Cables, Models AtarIKD · Special | Oscor, Inc. | 06/07/2007SE |
| K992372 | The LeadawayIKD · Traditional | Therapy Equipment, Inc. | 10/13/1999SE |
| K935260 | Physiometrix Cable Adapter ModificationIKD · Traditional | Physiometrix, Inc. | 12/23/1993SE |
| K834583 | Clear Leads-Radiotransparent WiresIKD · Traditional | Quinton, Inc. | 01/30/1984SE |
| K800934 | R2 Esu Cable-Adapter Models 160,161IKD · Traditional | R2 Corp. | 05/20/1980SE |
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Questions and answers
When was Life-Span Cable cleared by the FDA?
Life-Span Cable (K873361) received a 510(k) decision of Substantially Equivalent on November 9, 1987, 80 days after the submission was received.
What is the product code of K873361?
The FDA product code is IKD – Cable, Electrode, a Class II (moderate risk) device regulated under 21 CFR 890.1175.