FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BOTTLE, CONDENSATE (#1628)
K Number: K760082
·
Decision Jul 16, 1976
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
2
Applicant Total
20
Review Days
25
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Basic Information
- Device Name
- BOTTLE, CONDENSATE (#1628)
- K Number
- K760082
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Inspiron Corp.
- Date Received
- June 21, 1976
- Decision Date
- July 16, 1976
- Product Code
- CBC
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| CBC | Bottle, Collection And Trap, Breathing System (Uncalibrated) | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CBC), ordered by most recent decision date.
BIRD 1000 PV PORTABLE VENTILATOR
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FDA Class 2
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AMBU SUCTION BOOSTER
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 |
| K840935 | MANUAL RESUSCITATION SYSTEM | Apr 5, 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 |