FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MARZ-175
K Number: K811199
·
Decision May 21, 1981
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
57
Applicant Total
4
Review Days
21
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
- MARZ-175
- K Number
- K811199
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.1100
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Emde Corp.
- Date Received
- April 30, 1981
- Decision Date
- May 21, 1981
- Product Code
- CBT
- 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 |
|---|---|---|---|
| CBT | Arterial Blood Sampling Kit | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CBT), ordered by most recent decision date.
HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM
FDA 510(k)
FDA Class 1
·Anesthesiology
SECURE ARTERIAL BLOOD SAMPLING SYSTEM
FDA 510(k)
FDA Class 1
·Anesthesiology
ABC IN-LINE BLOOD SAMPLING KIT
FDA 510(k)
FDA Class 1
·Anesthesiology
ABG POINT LOK NEEDLE PROTECTION DEVICE
FDA 510(k)
FDA Class 1
·Anesthesiology
ACTI-FLEX ARTERIAL EXTENSION SET
FDA 510(k)
FDA Class 1
·Anesthesiology
NEEDLE SAFETY COVER
FDA 510(k)
FDA Class 1
·Anesthesiology