FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INCUBATOR, PORTABLE, ACT-STAT
K Number: K770914
·
Decision Aug 4, 1977
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
13
Applicant Total
4
Review Days
77
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
- INCUBATOR, PORTABLE, ACT-STAT
- K Number
- K770914
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5400
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Thermolyne Corp.
- Date Received
- May 19, 1977
- Decision Date
- August 4, 1977
- Product Code
- KQG
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| KQG | Instrument, Coagulation | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KQG), ordered by most recent decision date.
COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON
FDA 510(k)
FDA Class 2
·Hematology
PACIFIC HEMOSTASIS THROMBOSCREEN 400C
FDA 510(k)
FDA Class 2
·Hematology
PACIFIC HEMOSTASIS THROMBOSCREEN 200
FDA 510(k)
FDA Class 2
·Hematology
HEMOCHRON RESPONSE
FDA 510(k)
FDA Class 2
·Hematology
ELVI 828 DIGICLOT MULTISCAN
FDA 510(k)
FDA Class 2
·Hematology