FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEBULIZER SYSTEM
K Number: K922623
·
Decision Dec 1, 1992
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
73
Applicant Total
35
Review Days
182
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Basic Information
- Device Name
- NEBULIZER SYSTEM
- K Number
- K922623
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.6250
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Healthdyne, Inc.
- Date Received
- June 2, 1992
- Decision Date
- December 1, 1992
- Product Code
- BTI
- 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 |
|---|---|---|---|
| BTI | Compressor, Air, Portable | FDA class 2 | Anesthesiology |
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| K910118 | DATA RECORDER | Feb 14, 1991 | Substantially Equivalent |
| K903287 | MODEL 900S APNEA/HEART MONITOR | Aug 17, 1990 | Substantially Equivalent |
| K894030 | MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR | Jan 22, 1990 | Substantially Equivalent |
| K892006 | HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S | May 23, 1989 | Substantially Equivalent |
| K890150 | H-3000 OXYGEN CONCENTRATOR | Jan 31, 1989 | Substantially Equivalent |