FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MONITOR METEOR 100, CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MO
K Number: K982487
·
Decision Oct 14, 1998
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
89
Applicant Total
1
Review Days
89
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Basic Information
- Device Name
- CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MONITOR METEOR 100, CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MO
- K Number
- K982487
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1880
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cardiopulmonary Technologies, Inc.
- Date Received
- July 17, 1998
- Decision Date
- October 14, 1998
- Product Code
- BZC
- 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 |
|---|---|---|---|
| BZC | Calculator, Pulmonary Function Data | FDA class 2 | Anesthesiology |
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