FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KIT, PREP, INSPIRON IV
K Number: K760313
·
Decision Aug 4, 1976
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
35
Applicant Total
20
Review Days
9
Basic Information
- Device Name
- KIT, PREP, INSPIRON IV
- K Number
- K760313
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5420
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- INSPIRON CORP.
- Date Received
- July 26, 1976
- Decision Date
- August 4, 1976
- Product Code
- KZD
- 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 |
|---|---|---|---|
| KZD | Infusor, Pressure, For I.V. Bags | FDA class 1 | General Hospital |
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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 |
| K772069 | VOL. VENTILATOR SETUP W/OUT NEBULIZER | Nov 15, 1977 | Substantially Equivalent |
| K772070 | VENTILATOR SETUP, VOLUME | Nov 15, 1977 | Substantially Equivalent |
| K772071 | MANIFOLD & NEBU. FOR SINGLE LINE MACH. | Nov 15, 1977 | Substantially Equivalent |