510(k) clearance
Infinity® Acute Care System (IACS) – VG8.1
- 510(k) number
- K260579
- Applicant
- Draeger Medical Systems, Inc.
- Decision date
- Aug 20, 2026
- Date received
- Feb 20, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- MHX
- Device type
- Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Device class
- Class II
- Regulation
- 21 CFR 870.1025
- Advisory committee
- Cardiovascular
- Statement or summary
- Summary
- Third party
- N
- Location
- Andover, MA, US