510(k) K842302
- Device
- Fluid Warmer
- Applicant
- ORGANON TEKNIKA CORP.
- 510(k) number
- K842302
- Product code
- FLA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-08-27
- Date received
- 1984-06-11
- Regulation
- 876.5820
- Classification name
- Monitor, Temperature, Dialysis
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3003464075
- 3014856521
- 9616074
Source Documents#
510(k) summary PDF not indicated by FDA