DRI SLEEPER— 510(k) K934369
Substantially EquivalentLaborie Medical Technologies, Ltd.
FDA 510(k) clearance K934369 for DRI SLEEPER, Substantially Equivalent on 1993-11-24. Applicant: Laborie Medical Technologies, Ltd.. Device class: 2.
Clearance details
- Applicant
- Laborie Medical Technologies, Ltd.
- Product code
- Code KPN
- Device class
- Class 2
- Regulation
- 21 CFR 876.2040
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mississauga, CA
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