FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BRUSHRITE
K Number: K880442
·
Decision May 16, 1988
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
0
Applicant Total
1
Review Days
104
Basic Information
- Device Name
- BRUSHRITE
- K Number
- K880442
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1075
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Pro Care Laboratories, Inc.
- Date Received
- February 2, 1988
- Decision Date
- May 16, 1988
- Product Code
- JEG
- 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 |
|---|---|---|---|
| JEG | Analyzer, Gas, Argon, Gaseous-Phase | FDA class 2 | Anesthesiology |