FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FOCUS
K Number: K001729
·
Decision Jul 13, 2000
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
189
Applicant Total
20
Review Days
36
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Basic Information
- Device Name
- FOCUS
- K Number
- K001729
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Instrumentarium Corp.
- Date Received
- June 7, 2000
- Decision Date
- July 13, 2000
- 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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| K962638 | TONOCAP, TC-200 AND ACCESSORY CATHETERS | Apr 4, 1997 | Substantially Equivalent |
| K961441 | TONOMETERED SLAINE BLOOD GAS CONTROL | Apr 30, 1996 | Substantially Equivalent |
| 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 |