SmartSpectra Vital Signs Monitor 1.0— 510(k) K254169
Substantially EquivalentPresage Security, Inc. d/b/a Presage Technologies, Inc.
FDA 510(k) clearance K254169 for SmartSpectra Vital Signs Monitor 1.0, Substantially Equivalent on 2026-06-18. Applicant: Presage Security, Inc. d/b/a Presage Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Presage Security, Inc. d/b/a Presage Technologies, Inc.
- Product code
- Code QME
- Device class
- Class 2
- Regulation
- 21 CFR 870.2785
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Leesburg, VA, US
Recent devices under product code QME
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