DHD Emerald Product
FDA 510(k) K970596 · Dhd Diemolding Healthcare Div.
510(k) numberK970596
Submission
- Device name
- DHD Emerald Product
- Applicant
- Dhd Diemolding Healthcare Div.
Wampsville, NY, US - Received
- February 18, 1997
- Decision date
- May 16, 1997
- 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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| K192000 | D R Burton OxyPAPBWF · Traditional | D R Burton Healthcare, LLC | 02/19/2020SE |
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More from Teleflexmedical, Inc.
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| K973532 | Stealth, Metered Dose Inhaler (Mdi) Spacer Without Integral ActuatorCAF · Traditional | 03/19/1998SE |
| K961973 | DHD Ace with Mask KitCAF · Traditional | 08/15/1996SE |
| K953206 | DHD Metered Dose Inhaler (Mdi) Spacer (Modification)CAF · Traditional | 08/28/1995SE |
| K945118 | Expiratory Breathing ExerciserBWF · Traditional | 01/13/1995SE |
| K944900 | TherapepBWF · Traditional | 01/06/1995SE |
| K926301 | Ace Aerosol Enhancer, Hand Held Oral Inhalation CoCAF · Traditional | 07/21/1993SE |
| K922537 | DuralifeBZA · Traditional | 12/04/1992SE |
| K913726 | Duralife(Tm)BZA · Traditional | 02/07/1992SE |
| K913326 | DHD Metered Dose Inhaler (Mdi) SpacerCAF · Traditional | 01/07/1992SE |
| K911294 | Ultraset CatheterBZA · Traditional | 06/10/1991SE |
Questions and answers
When was DHD Emerald Product cleared by the FDA?
DHD Emerald Product (K970596) received a 510(k) decision of Substantially Equivalent on May 16, 1997, 87 days after the submission was received.
What is the product code of K970596?
The FDA product code is BWF – Spirometer, Therapeutic (Incentive), a Class II (moderate risk) device regulated under 21 CFR 868.5690.