FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OXYGEN THERAPY REGULATOR
K Number: K894302
·
Decision Aug 7, 1989
Classifications
1
FEI Numbers
111
Registration Numbers
112
Same Product Code
54
Applicant Total
2
Review Days
96
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Basic Information
- Device Name
- OXYGEN THERAPY REGULATOR
- K Number
- K894302
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.2700
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Modern Engineering Co., Inc.
- Date Received
- May 3, 1989
- Decision Date
- August 7, 1989
- Product Code
- CAN
- 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 |
|---|---|---|---|
| CAN | Regulator, Pressure, Gas Cylinder | FDA class 1 | Anesthesiology |
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Other Clearances by Modern Engineering Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K894850 | 8053 TWO STAGE TYPE A-B NITROUS OXIDE THERAPY CYLI | Aug 31, 1989 | Substantially Equivalent |