FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DATUM
K Number: K942799
·
Decision Apr 13, 1995
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
56
Applicant Total
2
Review Days
302
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Basic Information
- Device Name
- DATUM
- K Number
- K942799
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5880
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Blease USA, Inc.
- Date Received
- June 15, 1994
- Decision Date
- April 13, 1995
- Product Code
- CAD
- 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 |
|---|---|---|---|
| CAD | Vaporizer, Anesthesia, Non-Heated | FDA class 2 | Anesthesiology |
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Other Clearances by Blease USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K051629 | BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000 | Sep 23, 2005 | Substantially Equivalent |