FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRO2 OXYGEN ANALYZER
K Number: K922438
·
Decision Mar 5, 1993
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
120
Applicant Total
7
Review Days
287
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Basic Information
- Device Name
- PRO2 OXYGEN ANALYZER
- K Number
- K922438
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1720
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Martech Medical Products, Inc.
- Date Received
- May 22, 1992
- Decision Date
- March 5, 1993
- Product Code
- CCL
- 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 |
|---|---|---|---|
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | FDA class 2 | 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 |
| K926007 | ACCESSORY TO PISTON SYRINGE | Feb 23, 1993 | Substantially Equivalent |
| K914778 | NEOLINE(TM) | Sep 16, 1992 | Unknown |
| K910970 | MARKSMAN ARTERIAL BLOOD GAS SYRINGE | Oct 15, 1991 | Substantially Equivalent |
| K890473 | NEEDLE GUARD(TM) | Apr 3, 1989 | Substantially Equivalent |