FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BARD-PARKER ARTERIAL MONITORING SYSTEM
K Number: K780939
·
Decision Jul 17, 1978
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
57
Applicant Total
632
Review Days
39
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Basic Information
- Device Name
- BARD-PARKER ARTERIAL MONITORING SYSTEM
- K Number
- K780939
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.1100
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Date Received
- June 8, 1978
- Decision Date
- July 17, 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 |
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Other Clearances by Bd Becton Dickinson Vacutainer Systems Preanalytic
| K Number | Device Name | ||
|---|---|---|---|
| K003062 | BACTEC MGIT 960 SIR KITS | Jun 6, 2001 | Substantially Equivalent |
| K003553 | 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE | Mar 21, 2001 | Substantially Equivalent |
| K003461 | BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE | Feb 1, 2001 | Substantially Equivalent |
| K002938 | B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 | Nov 29, 2000 | Substantially Equivalent |
| K001364 | BD DIRECTIGEN FLU A+B | Jun 28, 2000 | Substantially Equivalent |
| K000762 | MOXIFLOXACIN, 5 UG, BBL SENSI-DISC | Apr 25, 2000 | Substantially Equivalent |
| K000829 | GATIFLOXACIN, 5 UG, BBL SENSI-DISC | Apr 13, 2000 | Substantially Equivalent |
| K993186 | SYNERCID, 15 UG, BBL SENSI-DISC | Nov 3, 1999 | Substantially Equivalent |
| K992734 | BECTON DICKINSON SYRINGE | Oct 1, 1999 | Substantially Equivalent |
| K991551 | VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE | Sep 23, 1999 | Substantially Equivalent |