FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VIDEO CAMERA W/ ELECTRONIC SHUTTER MODEL VCE-10
K Number: K930053
·
Decision May 17, 1993
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
22
Applicant Total
49
Review Days
131
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Basic Information
- Device Name
- VIDEO CAMERA W/ ELECTRONIC SHUTTER MODEL VCE-10
- K Number
- K930053
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4160
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medical Devices, Inc.
- Date Received
- January 6, 1993
- Decision Date
- May 17, 1993
- Product Code
- FWF
- 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 |
|---|---|---|---|
| FWF | Camera, Television, Endoscopic, Without Audio | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Medical Devices, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K002280 | PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602 | Feb 5, 2001 | Substantially Equivalent |
| K930084 | MICRO-ARTHROSCOPE | Sep 1, 1995 | Substantially Equivalent for Some Indications |
| K943126 | ELECTROFLEX | Dec 5, 1994 | Substantially Equivalent |
| K940012 | SMARTBRACE ELECTRODE | Dec 5, 1994 | Substantially Equivalent |
| K935132 | HOME MICROCURRENT HMC | Mar 14, 1994 | Substantially Equivalent |
| K934619 | FLEXMATE | Feb 23, 1994 | Substantially Equivalent |
| K924897 | XENON ENDOSCOPIC ILLUMINATOR, MODEL XEI-300 | Jul 6, 1993 | Substantially Equivalent |
| K923914 | IF-II (TM), MODEL 7200 | Nov 6, 1992 | Substantially Equivalent |
| K920071 | MEDITRON AUTOMATIC ELECTRONIC INSUFF. MODEL AEI-15 | Jul 21, 1992 | Substantially Equivalent |
| K915694 | MEDITRON ELECTRONIC LAPAROSCOPIC INSUFFLATOR | Jun 18, 1992 | Substantially Equivalent |