Thera-Mist TM Volumina Incent Spirometer, P40000
FDA 510(k) K903489 · Pegasus Research Corp.
510(k) numberK903489
Submission
- Device name
- Thera-Mist TM Volumina Incent Spirometer, P40000
- Applicant
- Pegasus Research Corp.
Costa Mesa, CA, US - Received
- August 2, 1990
- Decision date
- December 10, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K020700 | PMH 5000 Heated Humidifier for Respiratory TherapyBTT · Traditional | 04/26/2004SE |
| K013856 | PMH 1000 Heated HumidifierBTT · Traditional | 02/21/2003SE |
| K983783 | Heated HumidifierBTT · Traditional | 10/24/2000SE |
| K962534 | Thera-Mist Nebulizer MODEL-P3000CAF · Traditional | 02/28/1997SE |
| K946057 | Aqualarm Moisture Sensor Model P85000BYH · Traditional | 05/05/1995SE |
| K915890 | Autoclavable Thera-Mist Humidifier P3600, ModifiedBTT · Traditional | 06/24/1992SE |
| K914465 | Autoclavable Version Thera-Mist Nebulizer, P32000CAF · Traditional | 03/31/1992SE |
| K894000 | Thera-Mist HumidifierBTT · Traditional | 08/28/1989SE |
| K893942 | Thera-Mist(Tm) Nebulizer, Model 30000CAF · Traditional | 08/28/1989SE |
Questions and answers
When was Thera-Mist TM Volumina Incent Spirometer, P40000 cleared by the FDA?
Thera-Mist TM Volumina Incent Spirometer, P40000 (K903489) received a 510(k) decision of Substantially Equivalent on December 10, 1990, 130 days after the submission was received.
What is the product code of K903489?
The FDA product code is BWF – Spirometer, Therapeutic (Incentive), a Class II (moderate risk) device regulated under 21 CFR 868.5690.