Eclipse MINI Model 98900
FDA 510(k) K212317 · Spacelabs Healthcare, Ltd.
510(k) numberK212317
Submission
- Device name
- Eclipse MINI Model 98900
- Applicant
- Spacelabs Healthcare, Ltd.
Hertford, GB - Received
- July 26, 2021
- Decision date
- November 7, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MWJ – Electrocardiograph, Ambulatory (Without Analysis)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2800
- Specialty
- Cardiovascular
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| K141156 | Spacelabs Healthcare Telemetry ReceiverMHX · Traditional | 09/09/2014SE |
| K130207 | Spacelabs Healthcare CardioexpressDPS · Traditional | 07/23/2013SE |
| K122146 | Xhibit Central Station, Model 96102MHX · Traditional | 04/22/2013SE |
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Questions and answers
When was Eclipse MINI Model 98900 cleared by the FDA?
Eclipse MINI Model 98900 (K212317) received a 510(k) decision of Substantially Equivalent on November 7, 2022, 469 days after the submission was received.
What is the product code of K212317?
The FDA product code is MWJ – Electrocardiograph, Ambulatory (Without Analysis), a Class II (moderate risk) device regulated under 21 CFR 870.2800.