FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDITRON AUTOMATIC ELECTRONIC INSUFF. MODEL AEI-15
K Number: K920071
·
Decision Jul 21, 1992
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
49
Review Days
196
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Basic Information
- Device Name
- MEDITRON AUTOMATIC ELECTRONIC INSUFF. MODEL AEI-15
- K Number
- K920071
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medical Devices, Inc.
- Date Received
- January 7, 1992
- Decision Date
- July 21, 1992
- Product Code
- GEI
- 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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| 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 |
| K930053 | VIDEO CAMERA W/ ELECTRONIC SHUTTER MODEL VCE-10 | May 17, 1993 | Substantially Equivalent |
| K923914 | IF-II (TM), MODEL 7200 | Nov 6, 1992 | Substantially Equivalent |
| K915694 | MEDITRON ELECTRONIC LAPAROSCOPIC INSUFFLATOR | Jun 18, 1992 | Substantially Equivalent |