FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RAMS (RANDOM ACCESS MASS SPECTROMETER) M-200 RESPIRATORY GAS MONITOR
K Number: K950101
·
Decision Mar 21, 1995
Classifications
1
FEI Numbers
54
Registration Numbers
54
Same Product Code
16
Applicant Total
82
Review Days
69
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Basic Information
- Device Name
- RAMS (RANDOM ACCESS MASS SPECTROMETER) M-200 RESPIRATORY GAS MONITOR
- K Number
- K950101
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1620
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Marquette Electronics, Inc.
- Date Received
- January 11, 1995
- Decision Date
- March 21, 1995
- Product Code
- CBS
- 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 |
|---|---|---|---|
| CBS | Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | FDA class 2 | Anesthesiology |
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|---|---|---|---|
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| K964750 | EAGLE 4000 PATIENT MONITOR | Feb 21, 1997 | Substantially Equivalent |
| K962551 | CARDIOSERV S | Nov 19, 1996 | Substantially Equivalent - Subject to Tracking Reg. |
| K960418 | EAGLE PATIENT MONITOR | Oct 2, 1996 | Substantially Equivalent |
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