FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO FOCUS
K Number: K022630
·
Decision Oct 9, 2002
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
189
Applicant Total
20
Review Days
63
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Basic Information
- Device Name
- MODIFICATION TO FOCUS
- K Number
- K022630
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Instrumentarium Corp.
- Date Received
- August 7, 2002
- Decision Date
- October 9, 2002
- Product Code
- EHD
- Advisory Committee
- Dental
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| EHD | Unit, X-Ray, Extraoral With Timer | FDA class 2 | Dental |
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|---|---|---|---|
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| K955018 | TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATOR | Jan 30, 1996 | Substantially Equivalent |
| K934478 | ALPHA STEREO | Jan 31, 1995 | Substantially Equivalent |
| K923433 | AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE | Jul 22, 1993 | Substantially Equivalent |
| K930338 | ORTHOCEPH OC100 | Apr 27, 1993 | Substantially Equivalent |