FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AEROMIST LT, MODEL HCS15004
K Number: K031686
·
Decision Jan 21, 2004
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
73
Applicant Total
238
Review Days
233
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Basic Information
- Device Name
- AEROMIST LT, MODEL HCS15004
- K Number
- K031686
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.6250
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medline Industries, Inc.
- Date Received
- June 2, 2003
- Decision Date
- January 21, 2004
- 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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