FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL SKCK STERILE KNOB COVER KIT
K Number: K870662
·
Decision Oct 28, 1987
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
3
Applicant Total
68
Review Days
251
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Basic Information
- Device Name
- MODEL SKCK STERILE KNOB COVER KIT
- K Number
- K870662
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2775
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Life-Tech Intl., Inc.
- Date Received
- February 19, 1987
- Decision Date
- October 28, 1987
- Product Code
- BXM
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BXM | Stimulator, Nerve, Ac-Powered | FDA class 2 | Anesthesiology |
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FDA Class 2
·Anesthesiology
VER MED A10011 PNS DUAL ELEMENT ELECTRODE
FDA 510(k)
FDA Class 2
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| K946108 | EAR-A-GATOR | Jun 13, 1995 | Substantially Equivalent |
| K913601 | MICROPHOR | Jul 15, 1994 | Substantially Equivalent |
| K940203 | TRIPLE LUMEN URODYNAMIC CATHETER WITH RADIOPAQUE MARKERS | Mar 30, 1994 | Substantially Equivalent |