FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇮 Finland
FS Ergo
K Number: K173646
·
Decision Dec 19, 2017
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
205
Applicant Total
10
Review Days
22
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Basic Information
- Device Name
- FS Ergo
- K Number
- K173646
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Palodex Group OY
- Date Received
- November 27, 2017
- Decision Date
- December 19, 2017
- 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 Palodex Group OY
| K Number | Device Name | ||
|---|---|---|---|
| K241249 | Orthopantomograph OP 3D LX (PAN 3D); Orthopantomograph OP 3D LX (PAN CEPH 3D) | Sep 12, 2024 | Substantially Equivalent |
| K230505 | Orthopantomograph OP 3D LX | Jun 9, 2023 | Substantially Equivalent |
| K180947 | Orthopantomograph OP 3D | Jun 7, 2018 | Substantially Equivalent |
| K163423 | Orthopantomograph OP300 | Aug 31, 2017 | Substantially Equivalent |
| K162799 | Cliniview | Apr 25, 2017 | Substantially Equivalent |
| K170813 | ORTHOPANTOMOGRAPH OP 3D | Apr 7, 2017 | Substantially Equivalent |
| K133544 | OP300 | Mar 26, 2014 | Substantially Equivalent |
| K130297 | SCANORA 3DX | May 29, 2013 | Substantially Equivalent |
| K122018 | OP300 | Dec 10, 2012 | Substantially Equivalent |