Cirqlator Intrathoracic Pressure Regulator (Itpr)
FDA 510(k) K070490 · Advanced Circulatory Systems, Inc.
510(k) numberK070490
Submission
- Device name
- Cirqlator Intrathoracic Pressure Regulator (Itpr)
- Applicant
- Advanced Circulatory Systems, Inc.
Bonita Springs, FL, US - Received
- February 20, 2007
- Decision date
- June 20, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BWF – Spirometer, Therapeutic (Incentive)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5690
- Specialty
- Anesthesiology
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| K222018 | Breathe+BWF · Traditional | Peep Medical, LLC Dba Go2 Devices | 06/02/2023SE |
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| K203378 | PulsehalerBWF · Traditional | Respinova, Ltd. | 03/31/2021SE |
| K192000 | D R Burton OxyPAPBWF · Traditional | D R Burton Healthcare, LLC | 02/19/2020SE |
| K181660 | Acapella Choice Blue Vibratory PEP DeviceBWF · Traditional | Smiths Medical | 10/24/2019SE |
| K183108 | Combined Aerobika OPEP and VersaPAP deviceBWF · Traditional | Trudell Medical International | 08/16/2019SE |
| K182847 | Hudson RCI Voldyne Volumetric ExerciserBWF · Traditional | Teleflexmedical, Inc. | 07/01/2019SE |
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Questions and answers
When was Cirqlator Intrathoracic Pressure Regulator (Itpr) cleared by the FDA?
Cirqlator Intrathoracic Pressure Regulator (Itpr) (K070490) received a 510(k) decision of Substantially Equivalent on June 20, 2007, 120 days after the submission was received.
What is the product code of K070490?
The FDA product code is BWF – Spirometer, Therapeutic (Incentive), a Class II (moderate risk) device regulated under 21 CFR 868.5690.