Huntleigh Flowpac FP2000
FDA 510(k) K871272 · Huntleigh Technology, Inc.
510(k) numberK871272
Submission
- Device name
- Huntleigh Flowpac FP2000
- Applicant
- Huntleigh Technology, Inc.
Manalapan, NJ, US - Received
- March 31, 1987
- Decision date
- June 25, 1987
- 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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| 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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| K924516 | OP3/VP4HGL · Traditional | 06/28/1993SE |
| K910188 | Flowplus AC330 Pump GarmentsJOW · Traditional | 05/28/1991SE |
| K900882 | Multi Dopplex, MD-1JAF · Traditional | 08/22/1990SE |
| K900618 | Huntleigh Fetal Doppler, FD-1 & Dopcord, D140KNG · Traditional | 04/25/1990SE |
| K890012 | Huntleigh Dynamic Flotation SystemFNM · Traditional | 03/29/1989SE |
| K884451 | Dopcord PPGJOM · Traditional | 01/12/1989SE |
| K881632 | Flowtron DVT System AC500 Pump, L501 GarmentJOW · Traditional | 09/26/1988SE |
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Questions and answers
When was Huntleigh Flowpac FP2000 cleared by the FDA?
Huntleigh Flowpac FP2000 (K871272) received a 510(k) decision of Substantially Equivalent on June 25, 1987, 86 days after the submission was received.
What is the product code of K871272?
The FDA product code is DRM – Compressor, Cardiac, External, a Class II (moderate risk) device regulated under 21 CFR 870.5200.