510(k) K040802
- Device
- HEMOSONIC 200HEMODYNAMIC MONITOR
- Applicant
- Arrow Intl., Inc.
- 510(k) number
- K040802
- Product code
- DPN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-04-28
- Date received
- 2004-03-29
- Regulation
- 862.3700
- Classification name
- Thin Layer Chromatography, Propoxyphene
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- WILLIAM G MCLAIN
- Address
- 2400 Bernville Rd. Reading PA US 19605 19605
FDA Registration Numbers#
- 3005984081
- 3005360469