FDA 510(k)
FDA class 1
Substantially Equivalent
🇩🇪 Germany
TELETOM(R)
K Number: K921626
·
Decision May 5, 1992
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
34
Applicant Total
16
Review Days
29
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Basic Information
- Device Name
- TELETOM(R)
- K Number
- K921626
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4960
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Berchtold Holding GmbH
- Date Received
- April 6, 1992
- Decision Date
- May 5, 1992
- Product Code
- FQO
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FQO | Table, Operating-Room, Ac-Powered | FDA class 1 | General, Plastic Surgery |
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|---|---|---|---|
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| K024132 | CHROMOPHARE X 65 | Mar 21, 2003 | Substantially Equivalent |
| K990656 | CHROMOPHARE D 530 LDR SURGICAL LIGHT | Jul 20, 1999 | Substantially Equivalent |
| K991527 | CHROMOPHARE D500, D530, D650 | May 27, 1999 | Substantially Equivalent |
| K974433 | CHROMOPHARE D 500, CHROMOPHARE D 530 | Feb 20, 1998 | Substantially Equivalent |
| K965130 | CHROMOPHARE | Jul 14, 1997 | Substantially Equivalent |
| K955750 | TELETOM | Feb 8, 1996 | Substantially Equivalent |
| K950932 | BIPOLAP HOOK ELECTRODE | Mar 15, 1995 | Substantially Equivalent |
| K944855 | CHROMOPHARE | Oct 19, 1994 | Substantially Equivalent |