FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MONOJECT ARTERIAL BLOOD SAMPLING DEVICE
K Number: K790196
·
Decision Mar 13, 1979
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
57
Applicant Total
62
Review Days
47
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
- MONOJECT ARTERIAL BLOOD SAMPLING DEVICE
- K Number
- K790196
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.1100
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Sherwood Medical Industries
- Date Received
- January 25, 1979
- Decision Date
- March 13, 1979
- 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
Other Clearances by Sherwood Medical Industries
| K Number | Device Name | ||
|---|---|---|---|
| K801070 | SHERWOOD DISPOSABLE ENDOMETRIAL SAMPLES | Jul 21, 1980 | Substantially Equivalent |
| K801071 | LANCER GLUCOSE RATE REAGENT KIT | May 23, 1980 | Substantially Equivalent |
| K792013 | LANCER L-INA HUMAN REFERENCE SERUM | Nov 13, 1979 | Substantially Equivalent |
| K792014 | LANCER L-INA BUFFER, POLYMER, WASH SOLU | Nov 13, 1979 | Substantially Equivalent |
| K782077 | LANCER ICE CUBE | Apr 3, 1979 | Substantially Equivalent |
| K790523 | ARGYLE ESOPHAGEAL STETHOSCOPE | Mar 27, 1979 | Substantially Equivalent |
| K790197 | REAGENT KIT, LANCER GLUCOSE | Mar 12, 1979 | Substantially Equivalent |
| K781459 | MONOJECT SCALE MAGNIFIER | Oct 24, 1978 | Substantially Equivalent |
| K781060 | MONOJECT ENDOSSEOUS DENTAL IMPLANT | Aug 14, 1978 | Substantially Equivalent |
| K772149 | LANCER BIOPSY HOLDER | Nov 22, 1977 | Substantially Equivalent |