510(k) K771516
- Device
- CAPILLARY SAMPLE LINE
- Applicant
- Mcgaw Respiratory Therapy
- 510(k) number
- K771516
- Product code
- CCI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-08-16
- Date received
- 1977-08-08
- Regulation
- 868.1690
- Classification name
- Analyzer, Gas, Nitrogen, Gaseous-Phase
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- 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#
- 3013500228
- 3008483389
- 3030733800
- 3010838917
- 3013596024
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CCI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K872024 | CO2/02 MONITOR MULTINEX | Datascope Corp. | 1988-03-31 |