Pylant Monitor— 510(k) K191858
Substantially EquivalentKal-Med, LLC
FDA 510(k) clearance K191858 for Pylant Monitor, Substantially Equivalent on 2020-02-24. Applicant: Kal-Med, LLC. Device class: 2.
Clearance details
- Applicant
- Kal-Med, LLC
- Product code
- Code BSK
- Device class
- Class 2
- Regulation
- 21 CFR 868.5750
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kensington, CT, US
Recent devices under product code BSK
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