FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DX1-PORTABLE
K Number: K951157
·
Decision Aug 11, 1995
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
89
Applicant Total
4
Review Days
150
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Basic Information
- Device Name
- DX1-PORTABLE
- K Number
- K951157
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1880
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Creative Biomedics, Inc.
- Date Received
- March 14, 1995
- Decision Date
- August 11, 1995
- Product Code
- BZC
- 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 |
|---|---|---|---|
| BZC | Calculator, Pulmonary Function Data | FDA class 2 | Anesthesiology |
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