FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
TEAM-UP TM DENTAL ELECTRONIC ANESTHESIA SYSTEM
K Number: K011001
·
Decision Jun 7, 2001
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
14
Applicant Total
24
Review Days
90
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Basic Information
- Device Name
- TEAM-UP TM DENTAL ELECTRONIC ANESTHESIA SYSTEM
- K Number
- K011001
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Satelec
- Date Received
- March 9, 2001
- Decision Date
- June 7, 2001
- Product Code
- LWM
- Advisory Committee
- Unknown
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| LWM | Device, Electrical Dental Anesthesia | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LWM), ordered by most recent decision date.
Dental Pain Eraser
FDA 510(k)
FDA Unclassified
·Unknown
Dental Pain Eraser
FDA 510(k)
FDA Unclassified
·Unknown
Dental Pain Eraser
FDA 510(k)
FDA Unclassified
·Unknown
3M DENTAL ELECTRONIC ANESTHESIA (DEA) SYSTEM 8670
FDA 510(k)
FDA Unclassified
·Unknown
3M DENTAL ELECTRONONIC ANESTHESIA (DEA0 SYSTEM 8670 ADDITIONAL APPLICATIONS
FDA 510(k)
FDA Unclassified
·Unknown
3M DENTAL ELECTRONIC ANESTHESIA (DEA) SYSTEM 8670 MODIFICATION
FDA 510(k)
FDA Unclassified
·Unknown
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