FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ODYSSEY INSTRUMENTATION SYSTEM
K Number: K981294
·
Decision Jul 8, 1998
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
12
Applicant Total
3
Review Days
90
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Basic Information
- Device Name
- ODYSSEY INSTRUMENTATION SYSTEM
- K Number
- K981294
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Automata Instrumentation, Inc.
- Date Received
- April 9, 1998
- Decision Date
- July 8, 1998
- Product Code
- FIZ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FIZ | Meter, Conductivity, Non-Remote | FDA class 2 | Gastroenterology, Urology |
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