510(k) K032291
- Device
- TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM
- Applicant
- LINDE MEDICAL SENSORS AG
- 510(k) number
- K032291
- Product code
- DOA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-08-24
- Date received
- 2003-07-24
- Regulation
- 862.3320
- Classification name
- Radioimmunoassay, Digoxin (125-i), Goat Antibody, Anion Exchange, Resin Sep.
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JEAN-PIERRE PALMA
- Address
- Austrasse 25 Ch-4051 Basel CH
FDA Registration Numbers#
- 3008483389
- 3013596024
- 3013500228
Source Documents#
Legacy Summary#
summary
FDA Review#
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