Suresigns VS2 Vital Signs Monitor, Suresigns VM1 Patient Monitor, Suresigns VS3 Cital Signs Monitor
FDA 510(k) K082280 · Philips Medical Systems North America Co.
510(k) numberK082280
Submission
- Device name
- Suresigns VS2 Vital Signs Monitor, Suresigns VM1 Patient Monitor, Suresigns VS3 Cital Signs Monitor
- Applicant
- Philips Medical Systems North America Co.
Bothell, WA, US - Received
- August 11, 2008
- Decision date
- October 8, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MHX – Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
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| K250349 | Vista CMSMHX · Traditional | Shanghai Draeger Medical Instrument Co., Ltd. | 04/24/2026SE |
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Questions and answers
When was Suresigns VS2 Vital Signs Monitor, Suresigns VM1 Patient Monitor, Suresigns VS3 Cital Signs Monitor cleared by the FDA?
Suresigns VS2 Vital Signs Monitor, Suresigns VM1 Patient Monitor, Suresigns VS3 Cital Signs Monitor (K082280) received a 510(k) decision of Substantially Equivalent on October 8, 2008, 58 days after the submission was received.
What is the product code of K082280?
The FDA product code is MHX – Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), a Class II (moderate risk) device regulated under 21 CFR 870.1025.