FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TRAY, ARTERIAL BLOOD GAS SAMPLING
K Number: K781857
·
Decision Dec 11, 1978
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
57
Applicant Total
26
Review Days
35
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Basic Information
- Device Name
- TRAY, ARTERIAL BLOOD GAS SAMPLING
- K Number
- K781857
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.1100
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Jelco Laboratories
- Date Received
- November 6, 1978
- Decision Date
- December 11, 1978
- 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
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Other Clearances by Jelco Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K791918 | JELCO WINGED INTRAVASCULAR CATHETER | Oct 2, 1979 | Substantially Equivalent |
| K791372 | JELCO & KVO CATHETER PLACEMENT UNIT | Sep 12, 1979 | Substantially Equivalent |
| K790967 | CATHETER METAL HUB/RADIOPAQUE | Jun 27, 1979 | Substantially Equivalent |
| K790968 | CATHETER METAL HUB/NONRADIOPAQUE | Jun 11, 1979 | Substantially Equivalent |
| K790471 | JELCO* DISC FILTER-0.2 MICRON | Apr 30, 1979 | Substantially Equivalent |
| K790186 | PROTECTIVSTABILIZER | Feb 26, 1979 | Substantially Equivalent |
| K790079 | NEEDLE, BLOOD COLLECTING | Feb 1, 1979 | Substantially Equivalent |
| K790107 | CATHETER TUBING MODIFICATION | Feb 1, 1979 | Substantially Equivalent |
| K780896 | NEEDLES, DESIGN CHANGE, IV CATHETERS | Aug 23, 1978 | Substantially Equivalent |
| K780519 | FILTER TUBE | May 9, 1978 | Substantially Equivalent |