FDA 510(k)
FDA class 1
Substantially Equivalent
🇫🇮 Finland
ADMARK
K Number: K923533
·
Decision Mar 4, 1993
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
17
Applicant Total
13
Review Days
231
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Basic Information
- Device Name
- ADMARK
- K Number
- K923533
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1640
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Planmeca USA, Inc.
- Date Received
- July 16, 1992
- Decision Date
- March 4, 1993
- Product Code
- JAC
- Advisory Committee
- Radiology
- 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 |
|---|---|---|---|
| JAC | System, X-Ray, Film Marking, Radiographic | FDA class 1 | Radiology |
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Other Clearances by Planmeca USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K111361 | PLANMED NUANCE EXCEL | Sep 23, 2011 | Substantially Equivalent |
| K081699 | PLANMECA SOVEREIGN | Aug 29, 2008 | Substantially Equivalent |
| K923534 | PM2002 PROLINE | Jan 31, 1994 | Substantially Equivalent |
| K923462 | DELIGHT | Dec 21, 1992 | Substantially Equivalent |
| K923461 | PM2002 PROLINE, PM2002 PROLINE EC | Dec 21, 1992 | Substantially Equivalent |
| K904953 | PLANMED SOPHIE | Apr 18, 1991 | Substantially Equivalent |
| K904947 | PM2002 CC, ARISTOCRAT AND ARISTOCRAT DELUXE | Jan 30, 1991 | Substantially Equivalent |
| K904948 | PM2002 CC AND PM2002 EC | Jan 30, 1991 | Substantially Equivalent |
| K864474 | DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMIC | Nov 26, 1986 | Substantially Equivalent |
| K842359 | AUTOMATIC PATIENT CHAIR PM2000 & A | Sep 19, 1984 | Substantially Equivalent |