FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANALOR FOUR-ORAL SURGERY MODEL
K Number: K801101
·
Decision Jun 17, 1980
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
42
Applicant Total
6
Review Days
39
Basic Information
- Device Name
- ANALOR FOUR-ORAL SURGERY MODEL
- K Number
- K801101
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5270
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- NARCO MCKESSON CO.
- Date Received
- May 9, 1980
- Decision Date
- June 17, 1980
- Product Code
- BZE
- 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 |
|---|---|---|---|
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | FDA class 2 | Anesthesiology |
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Other Clearances by NARCO MCKESSON CO.
| K Number | Device Name | ||
|---|---|---|---|
| K801102 | COMPALOR-ORAL SURGERY MODEL | Jun 17, 1980 | Substantially Equivalent |
| K801103 | COMPALOR-DENTAL MODEL | May 28, 1980 | Substantially Equivalent |
| K801100 | ANALOR FOUR-DENTAL MODEL | May 28, 1980 | Substantially Equivalent |
| K790456 | SERIES 7000 | Mar 23, 1979 | Substantially Equivalent |
| K781492 | SERIES 7000 GAS MACHINE | Sep 11, 1978 | Substantially Equivalent |