Parapac 200 Medic, Model P200, & Parapac 200D Medic, Model P200D
FDA 510(k) K020899 · Pneupac , Ltd.
510(k) numberK020899
Submission
- Device name
- Parapac 200 Medic, Model P200, & Parapac 200D Medic, Model P200D
- Applicant
- Pneupac , Ltd.
Waukesha, WI, US - Received
- March 20, 2002
- Decision date
- December 13, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BTL – Ventilator, Emergency, Powered (Resuscitator)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5925
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
Other 510(k)s with product code BTL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242769 | VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)BTL · Traditional | Draegerwerk AG & CO Kgaa | 04/04/2025SE |
| K221634 | Oxymag - Transport and Emergency VentilatorBTL · Traditional | Magnamed Tecnologia Medica S/A | 05/24/2023SE |
| K202219 | VORTRAN GO2VENT with PEEP ValveBTL · Traditional | Vortran Medical Technology 1, Inc. | 02/11/2021SE |
| K193191 | MEDUMAT Easy CPR, MEDUMAT Easy CPR with bagBTL · Traditional | Weinmann Emergency Medical Technology GmbH + Co.… | 11/20/2020SE |
| K182956 | Puffin Lite Infant Resuscitation SystemBTL · Special | International Biomedical | 01/18/2019SE |
| K173373 | SafeT T-Piece ResuscitatorBTL · Traditional | Ventlab, LLC | 11/16/2018SE |
| K161420 | Moves SLCBTL · Traditional | Thornhill Research, Inc. | 06/06/2017SE |
| K162968 | Vortran GO2VENTBTL · Traditional | Vortran Medical Technology 1, Inc. | 04/10/2017SE |
| K141595 | O-Two E700,O-TWO E600,O-TWO E500BTL · Traditional | O-Two Medical Technologies, Inc. | 03/16/2015SE |
| K142096 | T-Piece ResuscitatorBTL · Traditional | Mercury Medical | 10/17/2014SE |
More from Mercury Medical
| 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 |
| 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 |
| K820220 | Ventilator ModelsCBK · Traditional | 02/18/1982SE |
Questions and answers
When was Parapac 200 Medic, Model P200, & Parapac 200D Medic, Model P200D cleared by the FDA?
Parapac 200 Medic, Model P200, & Parapac 200D Medic, Model P200D (K020899) received a 510(k) decision of Substantially Equivalent on December 13, 2002, 268 days after the submission was received.
What is the product code of K020899?
The FDA product code is BTL – Ventilator, Emergency, Powered (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5925.