FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANALGESIA UNITS, OXYGEN & NITRATE DEVICE
K Number: K800801
·
Decision May 28, 1980
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
187
Applicant Total
3
Review Days
48
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Basic Information
- Device Name
- ANALGESIA UNITS, OXYGEN & NITRATE DEVICE
- K Number
- K800801
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5160
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Spica, Inc.
- Date Received
- April 10, 1980
- Decision Date
- May 28, 1980
- Product Code
- BSZ
- 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 |
|---|---|---|---|
| BSZ | Gas-Machine, Anesthesia | FDA class 2 | Anesthesiology |
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