FDA 510(k)
FDA class 1
Unknown
🇺🇸 United States
NEOLINE(TM)
K Number: K914778
·
Decision Sep 16, 1992
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
57
Applicant Total
7
Review Days
329
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Basic Information
- Device Name
- NEOLINE(TM)
- K Number
- K914778
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.1100
- Medical Specialty
- Anesthesiology
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Martech Medical Products, Inc.
- Date Received
- October 23, 1991
- Decision Date
- September 16, 1992
- 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 Martech Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K960519 | MARTECH ENDOSCOPIC INJECTION NEEDLE | May 1, 1996 | Substantially Equivalent |
| K931924 | MARKSMAN ARTERIAL BLOOD GAS SYRINGE | Aug 3, 1993 | Substantially Equivalent |
| K922438 | PRO2 OXYGEN ANALYZER | Mar 5, 1993 | Substantially Equivalent |
| K926007 | ACCESSORY TO PISTON SYRINGE | Feb 23, 1993 | Substantially Equivalent |
| K910970 | MARKSMAN ARTERIAL BLOOD GAS SYRINGE | Oct 15, 1991 | Substantially Equivalent |
| K890473 | NEEDLE GUARD(TM) | Apr 3, 1989 | Substantially Equivalent |