Model 5320 Ted Sequential Comp. De. Comp. Limb Sle
FDA 510(k) K854734 · Medasonics, Inc.
510(k) numberK854734
Submission
- Device name
- Model 5320 Ted Sequential Comp. De. Comp. Limb Sle
- Applicant
- Medasonics, Inc.
Mountain View, CA, US - Received
- November 25, 1985
- Decision date
- February 10, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRM – Compressor, Cardiac, External
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5200
- Specialty
- Cardiovascular
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|---|---|---|---|
| K221700 | AutoPulse NXT Resuscitation SystemDRM · Traditional | Zoll Circulation, Inc. | 03/09/2023SE |
| K211289 | RMU-2000 Automated Chest Compression SystemDRM · Traditional | Defibtech, LLC | 11/09/2021SE |
| K173553 | LUCAS 3 Chest Compression SystemDRM · Traditional | Jolife AB | 02/08/2018SE |
| K161768 | LUCAS 3 Chest Compression SystemDRM · Traditional | Jolife AB | 11/09/2016SE |
| K153628 | ROSC-U Mini Chest Compressor (RMCC)DRM · Traditional | Resuscitation International, LLC | 01/30/2016SE |
| K141809 | RMU-1000 Automated Chest Compression SystemDRM · Traditional | Defibtech, LLC | 10/27/2014SE |
| K112998 | Autopulse Resuscitation System Model 1000DRM · Traditional | Zoll Circulation | 03/15/2012SE |
| K102068 | Miniaturize Chest Compressor (MCC)DRM · Traditional | Resuscitation International | 11/16/2010SE |
| K090422 | Lucas 2DRM · Traditional | Jolife AB | 06/17/2009SE |
| K072527 | Autopulse Resuscitation System, Model 100DRM · Traditional | Zoll Circulation | 03/19/2008SE |
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|---|---|---|
| K991441 | Cadence Doppler Ultrasound SystemKNG · Traditional | 12/28/1999SE |
| K962796 | Neuroguard Transcranial Doppler Ultrasound SystemIYN · Traditional | 01/21/1997SE |
| K961116 | First Beat/Cardio Beat/CalcIYO · Traditional | 08/08/1996SE |
| K914862 | Cerebrovascular Diagnostic System; CDSIYN · Traditional | 12/03/1992SE |
| K911453 | Obtrasound Stethoscope Fetal CalcKNG · Traditional | 06/20/1991SE |
| K882018 | Medacord PVL, Personal Vascular LaboratoryJAF · Traditional | 09/21/1988SE |
| K872292 | Transpect Transcranial DopplerIYN · Traditional | 08/14/1987SE |
| K833588 | Vascular Laboratory Treadmill VT1IOL · Traditional | 11/14/1983SE |
| K837481 | BF24 Doppler Model P872 and P874 · Traditional | 06/24/1983SE |
| K831393 | Vasculab Blood Pressure CuffDXQ · Traditional | 06/16/1983SE |
Questions and answers
When was Model 5320 Ted Sequential Comp. De. Comp. Limb Sle cleared by the FDA?
Model 5320 Ted Sequential Comp. De. Comp. Limb Sle (K854734) received a 510(k) decision of Substantially Equivalent on February 10, 1986, 77 days after the submission was received.
What is the product code of K854734?
The FDA product code is DRM – Compressor, Cardiac, External, a Class II (moderate risk) device regulated under 21 CFR 870.5200.