510(k) K771368
- Device
- PORTABLE INFANT VENTILATOR
- Applicant
- Cavitron Corp.
- 510(k) number
- K771368
- Product code
- FOC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-08-04
- Date received
- 1977-07-25
- Regulation
- 876.5250
- Classification name
- Bag, Urine Collection, Newborn
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3013557562
- 9680340
- 3008850249
- 3018762668
- 3030733800
- 1836161
- 1048735
- 3031981428
- 3030516433
- 3018077422
Source Documents#
510(k) summary PDF not indicated by FDA