510(k) K872024
- Device
- CO2/02 MONITOR MULTINEX
- Applicant
- DATASCOPE CORP.
- 510(k) number
- K872024
- Product code
- CCI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-03-31
- Date received
- 1987-05-26
- 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
- No
Applicant Contact#
- Contact
- ARTHUR FRIEDMAN
- Address
- 580 Winters Ave. P.O. Box 5 Paramus NJ US 07653 07653
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 |
|---|---|---|---|
| K771516 | CAPILLARY SAMPLE LINE | Mcgaw Respiratory Therapy | 1977-08-16 |
Legacy Summary#
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FDA Review#
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