FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MANUAL RESUSCITATION SYSTEM
K Number: K840935
·
Decision Apr 5, 1984
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
208
Applicant Total
20
Review Days
31
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Basic Information
- Device Name
- MANUAL RESUSCITATION SYSTEM
- K Number
- K840935
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5915
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Inspiron Corp.
- Date Received
- March 5, 1984
- Decision Date
- April 5, 1984
- Product Code
- BTM
- 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 |
|---|---|---|---|
| BTM | Ventilator, Emergency, Manual (Resuscitator) | FDA class 2 | Anesthesiology |
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FDA 510(k)
FDA Class 2
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Other Clearances by Inspiron Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K860838 | INSPIRON DOUBLE SWIVEL TRACH ADAPTER | Apr 9, 1986 | Substantially Equivalent |
| K850346 | OXYGEN CONCENTRATOR | Feb 4, 1985 | Substantially Equivalent |
| K843932 | VAPOR-PHASE HUMIDIFIER SYS-ADVANCED | Oct 18, 1984 | Substantially Equivalent |
| K841158 | NEBULO 28 NEBULIZER KIT | Mar 30, 1984 | Substantially Equivalent |
| K840418 | INSPIRATORY/EXPIRATORY MUSCLE EXERCIS | Feb 17, 1984 | Substantially Equivalent |
| K834290 | INSPIRON LIQUID OXYGEN SYSTEM | Feb 4, 1984 | Substantially Equivalent |
| K772070 | VENTILATOR SETUP, VOLUME | Nov 15, 1977 | Substantially Equivalent |
| K772069 | VOL. VENTILATOR SETUP W/OUT NEBULIZER | Nov 15, 1977 | Substantially Equivalent |
| K772068 | MANIFOLD & NEBULIZER, UNIVERSAL | Nov 15, 1977 | Substantially Equivalent |
| K772072 | MANIFOLD & NEBU. FOR DOUB. LINE MACH. | Nov 15, 1977 | Substantially Equivalent |