Fetalgard Lite-Nibp, Model Fgl-Nibp
FDA 510(k) K051903 · Analogic Corporation
510(k) numberK051903
Submission
- Device name
- Fetalgard Lite-Nibp, Model Fgl-Nibp
- Applicant
- Analogic Corporation
Peabody, MA, US - Received
- July 13, 2005
- Decision date
- December 27, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXN – System, Measurement, Blood-Pressure, Non-Invasive
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1130
- Specialty
- Cardiovascular
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| K254000 | Happy Health Blood Pressure MonitorDXN · Traditional | Happy Health, Inc. | 09/03/2026SE |
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| K253126 | Wrist Blood Pressure Monitor (XW-05)DXN · Traditional | Shenzhen Ziqing Medical Equipment Co., Ltd. | 06/18/2026SE |
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Questions and answers
When was Fetalgard Lite-Nibp, Model Fgl-Nibp cleared by the FDA?
Fetalgard Lite-Nibp, Model Fgl-Nibp (K051903) received a 510(k) decision of Substantially Equivalent on December 27, 2005, 167 days after the submission was received.
What is the product code of K051903?
The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.