ESCREEN SYSTEM— 510(k) K003352
Substantially EquivalentEscreen, Inc.
FDA 510(k) clearance K003352 for ESCREEN SYSTEM, Substantially Equivalent on 2001-03-20. Applicant: Escreen, Inc.. Device class: 2.
Clearance details
- Applicant
- Escreen, Inc.
- Product code
- Product code LAF
- Device class
- Class 2
- Regulation
- 21 CFR 862.3610
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Washington, DC, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.