Threshold 2X Inspiratory Muscle Trainer
FDA 510(k) K912943 · Health Products, Inc.
510(k) numberK912943
Submission
- Device name
- Threshold 2X Inspiratory Muscle Trainer
- Applicant
- Health Products, Inc.
Cedar Grove, NJ, US - Received
- July 5, 1991
- Decision date
- January 30, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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More from Teleflexmedical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K912866 | Peak Expiratory Flow MeterBZH · Traditional | 08/13/1992SE |
| K911807 | Metered Dose Inhaler (Mdi) SpacerCAF · Traditional | 10/23/1991SE |
| K902292 | Modified Assess(R) Peak Flow MeterBZH · Traditional | 08/10/1990SE |
| K896953 | Modified Assess(R) Peak Flow MeterBZH · Traditional | 01/30/1990SE |
| K894353 | Orthoderm ConvertibleIOQ · Traditional | 08/09/1989SE |
| K890426 | Consummate Air Therapy BedFNL · Traditional | 04/05/1989SE |
| K874801 | Orthoderm Therapy BedFNM · Traditional | 02/05/1988SE |
| K871742 | Modified Use of Plex Inspiratory Muscle TrainerBWF · Traditional | 06/15/1987SE |
| K870514 | Threshold(Tm) Inspiratory Muscle TrainerBWF · Traditional | 03/31/1987SE |
| K864719 | Pflex Em(Tm) (Exercise Monitor)BWF · Traditional | 03/16/1987SE |
Questions and answers
When was Threshold 2X Inspiratory Muscle Trainer cleared by the FDA?
Threshold 2X Inspiratory Muscle Trainer (K912943) received a 510(k) decision of Substantially Equivalent on January 30, 1992, 209 days after the submission was received.
What is the product code of K912943?
The FDA product code is BWF – Spirometer, Therapeutic (Incentive), a Class II (moderate risk) device regulated under 21 CFR 868.5690.