FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MARKSMAN ARTERIAL BLOOD GAS SYRINGE
K Number: K910970
·
Decision Oct 15, 1991
Classifications
1
FEI Numbers
218
Registration Numbers
218
Same Product Code
235
Applicant Total
7
Review Days
222
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Basic Information
- Device Name
- MARKSMAN ARTERIAL BLOOD GAS SYRINGE
- K Number
- K910970
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1675
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Martech Medical Products, Inc.
- Date Received
- March 7, 1991
- Decision Date
- October 15, 1991
- Product Code
- JKA
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | FDA class 2 | Clinical Chemistry |
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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 |
| K914778 | NEOLINE(TM) | Sep 16, 1992 | Unknown |
| K890473 | NEEDLE GUARD(TM) | Apr 3, 1989 | Substantially Equivalent |