FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIA
K Number: K000275
·
Decision Apr 12, 2000
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
56
Applicant Total
58
Review Days
72
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Basic Information
- Device Name
- DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIA
- K Number
- K000275
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.5880
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Datex-Ohmeda, Inc.
- Date Received
- January 31, 2000
- Decision Date
- April 12, 2000
- Product Code
- CAD
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CAD | Vaporizer, Anesthesia, Non-Heated | FDA class 2 | Anesthesiology |
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