FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE PORTABLE FAMILY - MEDI-FACTS DX1 PORTABLE LITE AND DX1 PORTABLE PLUS
K Number: K964939
·
Decision Mar 6, 1997
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
89
Applicant Total
4
Review Days
86
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- THE PORTABLE FAMILY - MEDI-FACTS DX1 PORTABLE LITE AND DX1 PORTABLE PLUS
- K Number
- K964939
- 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
- December 10, 1996
- Decision Date
- March 6, 1997
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BZC), ordered by most recent decision date.
STS
FDA 510(k)
FDA Class 2
·Anesthesiology
Vyntus/SentrySuite Product Line
FDA 510(k)
FDA Class 2
·Anesthesiology
Vyntus BODY
FDA 510(k)
FDA Class 2
·Anesthesiology
Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART
FDA 510(k)
FDA Class 2
·Anesthesiology
COSMED K5 Wearable Metabolic Technology
FDA 510(k)
FDA Class 2
·Anesthesiology
MiniBox +
FDA 510(k)
FDA Class 2
·Anesthesiology