FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INSPIRON NEBULO BASIC EXTERNAL HEATER
K Number: K880304
·
Decision Mar 4, 1988
Classifications
1
FEI Numbers
189
Registration Numbers
189
Same Product Code
507
Applicant Total
29
Review Days
39
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Basic Information
- Device Name
- INSPIRON NEBULO BASIC EXTERNAL HEATER
- K Number
- K880304
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5630
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Intertech Resources, Inc.
- Date Received
- January 25, 1988
- Decision Date
- March 4, 1988
- Product Code
- CAF
- 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 |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | FDA class 2 | Anesthesiology |
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| K952223 | XENON GAS BREATHING CIRCUIT | Aug 11, 1995 | Substantially Equivalent |
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| K935036 | HEPA FILTERED HEAT AND MOISTURE EXCHANGER | Jan 25, 1994 | Unknown |
| K930816 | HEPA FILTERED HME | Jul 1, 1993 | Substantially Equivalent |
| K922479 | DISPOSABLE ANESTHESIA BREATHING CIRCUIT, MODIFIED | Oct 30, 1992 | Substantially Equivalent |