Mcpulse
FDA 510(k) K023238 · Meridian Co., Ltd.
510(k) numberK023238
Submission
- Device name
- Mcpulse
- Applicant
- Meridian Co., Ltd.
Deer Field, IL, US - Received
- September 27, 2002
- Decision date
- February 19, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JOM – Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2780
- Specialty
- Cardiovascular
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| K020360 | ABR-2000GZO · Traditional | 08/29/2002SE |
Questions and answers
When was Mcpulse cleared by the FDA?
Mcpulse (K023238) received a 510(k) decision of Substantially Equivalent on February 19, 2003, 145 days after the submission was received.
What is the product code of K023238?
The FDA product code is JOM – Plethysmograph, Photoelectric, Pneumatic Or Hydraulic, a Class II (moderate risk) device regulated under 21 CFR 870.2780.