REMVIEW SLEEP RECORDER, MODEL 320— 510(k) K003499
Substantially EquivalentRespironics, Inc.
FDA 510(k) clearance K003499 for REMVIEW SLEEP RECORDER, MODEL 320, Substantially Equivalent on 2001-02-09. Applicant: Respironics, Inc.. Device class: 2.
Clearance details
- Applicant
- Respironics, Inc.
- Product code
- Code LEL
- Device class
- Class 2
- Regulation
- 21 CFR 882.5050
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Murrysville, PA, US
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