Pneupac Resuscitator Instant Action Set
FDA 510(k) K792454 · Pneupac , Ltd.
510(k) numberK792454
Submission
- Device name
- Pneupac Resuscitator Instant Action Set
- Applicant
- Pneupac , Ltd.
Mchenry, IL, US - Received
- December 3, 1979
- Decision date
- February 5, 1980
- 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
Other 510(k)s with product code DRM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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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| 510(k) | Device | Decision |
|---|---|---|
| K040090 | Comppac 200HD; CS12 Power Supply (Aircraft/Vechile); PS11 Power Supply (Mains)BTL · Traditional | 05/27/2004SE |
| K030803 | Parapac 200D Transport, Model V200DBTL · Traditional | 09/29/2003SE |
| K021841 | Comppac Ventilator Models 200 & PS11 Power Supply/ChargerBTL · Traditional | 07/17/2003SE |
| K020899 | Parapac 200 Medic, Model P200, & Parapac 200D Medic, Model P200DBTL · Traditional | 12/13/2002SE |
| K970158 | BabypacCBK · Traditional | 04/28/1998SE |
| K960515 | ParapacBTL · Traditional | 10/10/1996SE |
| K863410 | Patient Valve with Air EntrainmentBTL · Traditional | 01/12/1987SE |
| K862830 | Models 2R and 3R Pneupac Ventilator/ResuscitatorBTL · Traditional | 10/15/1986SE |
| K843737 | Pneupac Instant Action Ventilator/ResusCBK · Traditional | 10/04/1984SE |
| K832700 | Pneu Pac Ventilator/ResuscitatorsCBK · Traditional | 11/14/1983SE |
Questions and answers
When was Pneupac Resuscitator Instant Action Set cleared by the FDA?
Pneupac Resuscitator Instant Action Set (K792454) received a 510(k) decision of Substantially Equivalent on February 5, 1980, 64 days after the submission was received.
What is the product code of K792454?
The FDA product code is DRM – Compressor, Cardiac, External, a Class II (moderate risk) device regulated under 21 CFR 870.5200.