FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STRATASYS FDM MEDMODELER SYSTEM
K Number: K971290
·
Decision Jun 20, 1997
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
14
Review Days
74
Basic Information
- Device Name
- STRATASYS FDM MEDMODELER SYSTEM
- K Number
- K971290
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PALADIN MEDICAL, INC.
- Date Received
- April 7, 1997
- Decision Date
- June 20, 1997
- Product Code
- LLZ
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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| K Number | Device Name | ||
|---|---|---|---|
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| K970347 | MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEM | Aug 29, 1997 | Substantially Equivalent |
| K964222 | ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING | Dec 20, 1996 | Substantially Equivalent |
| K950054 | ENDO-BEND(TM) SHAVER | Jun 29, 1995 | Substantially Equivalent |
| K935220 | CORE PREVENT MATTRESS MODIFICATION | Nov 29, 1993 | Substantially Equivalent |
| K921015 | SHARPE ENDOSPONGE ASPIIRATOR | May 21, 1993 | Substantially Equivalent |
| K915743 | SHARPE ENDOTENACULUM | May 20, 1993 | Substantially Equivalent |
| K921888 | SHARPE ENDODISSECTOR | Oct 20, 1992 | Substantially Equivalent |
| K915749 | SHARPE ENDOLIGATURE CARRIER | Oct 20, 1992 | Substantially Equivalent |
| K915744 | SHARPE ENDOHEMOSTAT | Oct 20, 1992 | Substantially Equivalent |