FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GASEOUS OXYGEN ANALYZER (MODEL S-3A) MODIFICATION
K Number: K943824
·
Decision Nov 1, 1996
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
120
Applicant Total
2
Review Days
914
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Basic Information
- Device Name
- GASEOUS OXYGEN ANALYZER (MODEL S-3A) MODIFICATION
- K Number
- K943824
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1720
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ametek, Inc.
- Date Received
- May 2, 1994
- Decision Date
- November 1, 1996
- 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 Ametek, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K942113 | CARBON DIOXIDE ANALYZER (MODEL CD-3A) | Feb 16, 1995 | Substantially Equivalent |