FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORTHOPANTOMOGRAPH OP100D
K Number: K992385
·
Decision Sep 28, 1999
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
205
Applicant Total
20
Review Days
74
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Basic Information
- Device Name
- ORTHOPANTOMOGRAPH OP100D
- K Number
- K992385
- 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
- July 16, 1999
- Decision Date
- September 28, 1999
- Product Code
- MUH
- 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 |
|---|---|---|---|
| MUH | System, X-Ray, Extraoral Source, Digital | FDA class 2 | Dental |
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Other Clearances by Instrumentarium Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K022630 | MODIFICATION TO FOCUS | Oct 9, 2002 | Substantially Equivalent |
| K001729 | FOCUS | Jul 13, 2000 | Substantially Equivalent |
| K001439 | ORTHOCEPH OC100 D | Jun 22, 2000 | Substantially Equivalent |
| K981641 | MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQ | Jul 17, 1998 | Substantially Equivalent |
| 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 |