Portable Infant Ventilator
FDA 510(k) K771368 · Cavitron Corp.
510(k) numberK771368
Submission
- Device name
- Portable Infant Ventilator
- Applicant
- Cavitron Corp.
Mchenry, IL, US - Received
- July 25, 1977
- Decision date
- August 4, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FOC – Bag, Urine Collection, Newborn
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5250
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FOC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K950176 | Premie U-Bag Urine Specimen CollectorFOC · Traditional | Hollister, Inc. | 02/07/1995SE |
| K943752 | Rimeco Midstream Urine CollectorFOC · Traditional | Rimeco Products, Inc. | 11/01/1994SE |
| K911329 | Bard(R) Surecatch Pediatric Urine Collect DeviceFOC · Traditional | C.R. Bard, Inc. | 05/28/1991SE |
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| K802928 | Spirometric Computer #SC-10BZC · Traditional | 12/17/1980SE |
| K801623 | Cavitron Ultrasonic Surg. Aspir. CusaLFL · Traditional | 11/18/1980SE |
| K801877 | Slit Lamp AttachmentHQB · Traditional | 09/16/1980SE |
| K800869 | Model PM-20(N)(R)CO2 Patient Monitor/AlaCCK · Traditional | 05/28/1980SE |
| K800722 | Auto-Field D Automated Visual DetectorHPT · Traditional | 04/29/1980SE |
| K791585 | Model G-61 Ultrasonic Dental UnitELC · Traditional | 09/19/1979SE |
| K791277 | Model 6500 Extraction Irrigation SysHDQ · Traditional | 08/22/1979SE |
| K782054 | Laser, CO2 SurgicalHHR · Traditional | 01/17/1979SE |
Questions and answers
When was Portable Infant Ventilator cleared by the FDA?
Portable Infant Ventilator (K771368) received a 510(k) decision of Substantially Equivalent on August 4, 1977, 10 days after the submission was received.
What is the product code of K771368?
The FDA product code is FOC – Bag, Urine Collection, Newborn, a Class II (moderate risk) device regulated under 21 CFR 876.5250.