FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RESPIRATORY DIAGNOSTIC EQUIPMENT CALIBRATOR
K Number: K853848
·
Decision Dec 5, 1985
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
5
Applicant Total
23
Review Days
80
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Basic Information
- Device Name
- RESPIRATORY DIAGNOSTIC EQUIPMENT CALIBRATOR
- K Number
- K853848
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.1870
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Medical Graphics Corp.
- Date Received
- September 16, 1985
- Decision Date
- December 5, 1985
- Product Code
- BXW
- 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 |
|---|---|---|---|
| BXW | Calibrator, Volume, Gas | FDA class 1 | Anesthesiology |
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