FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IMPAX 1000
K Number: K933409
·
Decision Nov 3, 1993
Classifications
1
FEI Numbers
148
Registration Numbers
148
Same Product Code
141
Applicant Total
145
Review Days
114
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Basic Information
- Device Name
- IMPAX 1000
- K Number
- K933409
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.2020
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Heraeus Kulzer, Inc.
- Date Received
- July 12, 1993
- Decision Date
- November 3, 1993
- Product Code
- LMD
- 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 |
|---|---|---|---|
| LMD | System, Digital Image Communications, Radiological | FDA class 1 | Radiology |
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Other Clearances by Heraeus Kulzer, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K091494 | FLEXITIME FLOW | Jul 31, 2009 | Substantially Equivalent |
| K063062 | HKBOND 2006 | Dec 1, 2006 | Substantially Equivalent |
| K060994 | MONDIAL | May 22, 2006 | Substantially Equivalent |
| K052543 | HERACERAM ZIRKONIA | Oct 25, 2005 | Substantially Equivalent |
| K043504 | PALAIMPACT | Jan 28, 2005 | Substantially Equivalent |
| K043295 | VERSYO.DIRECT | Jan 5, 2005 | Substantially Equivalent |
| K042878 | FLEXITIME XTREME | Dec 17, 2004 | Substantially Equivalent |
| K030052 | OSTIM | Dec 6, 2004 | Substantially Equivalent |
| K040859 | HERACERAM PRESS | May 20, 2004 | Substantially Equivalent |
| K040043 | NDX-40 ALLOY | Mar 3, 2004 | Substantially Equivalent |