FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PISTON SYRINGE
K Number: K944941
·
Decision Dec 5, 1994
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
57
Applicant Total
7
Review Days
59
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Basic Information
- Device Name
- PISTON SYRINGE
- K Number
- K944941
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.1100
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Martell Medical Products, Inc.
- Date Received
- October 7, 1994
- Decision Date
- December 5, 1994
- 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 Martell Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K945454 | LEUR TIP CAP, VLT CAP(TM) | Apr 14, 1995 | Substantially Equivalent |
| K841810 | MARK5 ARTERIAL BLOOD GAS KIT | Jul 6, 1984 | Substantially Equivalent |
| K822786 | MDM ARTERIAL BLOOD GAS KIT | Oct 21, 1982 | Substantially Equivalent |
| K822760 | ARTERIAL LINE KIT | Sep 28, 1982 | Substantially Equivalent |
| K821096 | A-LINER | May 14, 1982 | Substantially Equivalent |
| K812560 | MDM ARTERIAL BLOOD GAS SYRINGE | Oct 9, 1981 | Substantially Equivalent |