Recomed Blood-Flow Meter H236-052-02
FDA 510(k) K840522 · Litton Medical Electronics
510(k) numberK840522
Submission
- Device name
- Recomed Blood-Flow Meter H236-052-02
- Applicant
- Litton Medical Electronics
Elk Grove Village, IL, US - Received
- February 7, 1984
- Decision date
- May 16, 1985
- 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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More from Remington Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K840899 | Servomed Arrhycomp Central Monitor SysDSI · Traditional | 11/20/1984SE |
| K840439 | Recomed Cardiac Output Meter 236067-DXG · Traditional | 11/20/1984SE |
| K840523 | Servomed Pulse Amplifier MODULE-206-DRT · Traditional | 10/29/1984SE |
| K840524 | Servomed Basic Bedside Unit SMV 110TPDRT · Traditional | 10/26/1984SE |
| K840832 | Servomed Oxcardiore Spirograph 324/111DRT · Traditional | 09/20/1984SE |
| K840209 | Servomed Medivision Scope SMV-235DXJ · Traditional | 09/20/1984SE |
| K840525 | Servomed Compact Monitor SMK 155-1/101DRT · Traditional | 06/01/1984SE |
| K840521 | Servomed Digital Display ModuleDRT · Traditional | 06/01/1984SE |
| K834600 | Recomb ECG PREAMPLIFIER/206 069 03DRT · Traditional | 06/01/1984SE |
| K833000 | I-Channel RecorderDSF · Traditional | 06/01/1984SE |
Questions and answers
When was Recomed Blood-Flow Meter H236-052-02 cleared by the FDA?
Recomed Blood-Flow Meter H236-052-02 (K840522) received a 510(k) decision of Substantially Equivalent on May 16, 1985, 464 days after the submission was received.
What is the product code of K840522?
The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.