FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMETEC MASY MODULAR ANGIOSCOPE SYSTEM
K Number: K905745
·
Decision Apr 23, 1992
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
40
Applicant Total
6
Review Days
486
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Basic Information
- Device Name
- AMETEC MASY MODULAR ANGIOSCOPE SYSTEM
- K Number
- K905745
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- American Medical Technology, Inc.
- Date Received
- December 24, 1990
- Decision Date
- April 23, 1992
- Product Code
- LYK
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| LYK | Angioscope | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by American Medical Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K963808 | CHOICE POWERED WHEELCHAIR | Feb 12, 1997 | Substantially Equivalent |
| K874567 | RESUSCITATOR | Feb 29, 1988 | Substantially Equivalent |
| K874430 | NEEDLE CONTAINER | Jan 4, 1988 | Substantially Equivalent |
| K874360 | PLASTIC TUBING CONNECTOR | Nov 17, 1987 | Substantially Equivalent |
| K873313 | SURGICAL DRAPE | Sep 4, 1987 | Substantially Equivalent |