FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POLYHESIVE MONITORING AND DIAGNOSTIC ELECTRODES
K Number: K885262
·
Decision Jan 25, 1989
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
328
Applicant Total
94
Review Days
33
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Basic Information
- Device Name
- POLYHESIVE MONITORING AND DIAGNOSTIC ELECTRODES
- K Number
- K885262
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2360
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Valleylab, Inc.
- Date Received
- December 23, 1988
- Decision Date
- January 25, 1989
- Product Code
- DRX
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DRX | Electrode, Electrocardiograph | FDA class 2 | Cardiovascular |
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| K981916 | LIGASURE VESSEL SEALING SYSTEM | Aug 28, 1998 | Substantially Equivalent |
| K981262 | CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM | Jul 6, 1998 | Substantially Equivalent |
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| K970140 | E0520-TRIGGER SWITCH AND CORD/E0521-TRIGGER SWITCH | Mar 28, 1997 | Substantially Equivalent |
| K964636 | FORCE ARGON II ARGON ENHANCED ELECTROSURGICAL SYSTEM | Mar 11, 1997 | Substantially Equivalent |