M4 Monitor
FDA 510(k) K110957 · Spectrum Medical, Llp
510(k) numberK110957
Submission
- Device name
- M4 Monitor
- Applicant
- Spectrum Medical, Llp
Gloucester, GB - Received
- April 5, 2011
- Decision date
- May 31, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- DRY – Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4330
- Specialty
- Cardiovascular
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|---|---|---|---|
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| K202154 | B-CaptaDRY · Traditional | Livanova Deutschland, GmbH | 04/01/2021SE |
| K202557 | Quantum Workstation 12 EliteDRY · Special | Spectrum Medical , Ltd. | 10/02/2020SE |
| K182110 | CDI Blood Parameter Monitoring System 550DRY · Traditional | Terumo Cardiovascular Systems Corporation | 11/02/2018SE |
| K181923 | Quantum Workstation 12.1DRY · Special | Spectrum Medical , Ltd. | 08/17/2018SE |
| K173591 | Quantum Diagnostic Module, Quantum Diagnostic Module - No GasDRY · Traditional | Spectrum Medical , Ltd. | 03/28/2018SE |
| K163657 | Quantum WorkstationDRY · Special | Spectrum Medical , Ltd. | 01/18/2017SE |
| K133157 | Tri-Optic Measurement Cell; with Balance Biosurface, with Carmeda Bioactive Surface…DRY · Traditional | Medtronic, Inc. | 10/23/2014SE |
| K133658 | Cdi Blood Parameter Monitoring System 500DRY · Traditional | Terumo Cardiovascular Systems Corp. | 07/25/2014SE |
| K123039 | Cdi Blood Parameter Monitoring System 500DRY · Traditional | Terumo Cardiovascular Systems Corp. | 11/20/2012SE |
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| K202557 | Quantum Workstation 12 EliteDRY · Special | 10/02/2020SE |
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| K181923 | Quantum Workstation 12.1DRY · Special | 08/17/2018SE |
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Questions and answers
When was M4 Monitor cleared by the FDA?
M4 Monitor (K110957) received a 510(k) decision of Substantially Equivalent on May 31, 2011, 56 days after the submission was received.
What is the product code of K110957?
The FDA product code is DRY – Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4330.