Modified Software to the Sonos 100 Ultrasound
FDA 510(k) K902088 · Hewlett-Packard Co.
510(k) numberK902088
Submission
- Device name
- Modified Software to the Sonos 100 Ultrasound
- Applicant
- Hewlett-Packard Co.
Andover, MA, US - Received
- May 10, 1990
- Decision date
- August 8, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DPW – Flowmeter, Blood, Cardiovascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2100
- Specialty
- Cardiovascular
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| K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810ADRG · Traditional | 12/20/1999SE |
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| K993516 | HP M2600A Viridia Telemetry SystemDSI · Special | 11/08/1999SE |
| K992674 | HP Viridia CMS Patient Monitor with EEG Parameter, Model M1027AMHX · Abbreviated | 11/08/1999SE |
| K993171 | HP Viridia Information System, Models M3150A/ M3151A/ M3153A/ M3154ADSI · Special | 10/21/1999SE |
Questions and answers
When was Modified Software to the Sonos 100 Ultrasound cleared by the FDA?
Modified Software to the Sonos 100 Ultrasound (K902088) received a 510(k) decision of Substantially Equivalent on August 8, 1990, 90 days after the submission was received.
What is the product code of K902088?
The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.