Medshield/Aerochamber
FDA 510(k) K961455 · Diemolding Corp.
510(k) numberK961455
Submission
- Device name
- Medshield/Aerochamber
- Applicant
- Diemolding Corp.
Canastota, NY, US - Received
- April 16, 1996
- Decision date
- July 25, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CCQ – Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5640
- Specialty
- Anesthesiology
Other 510(k)s with product code CCQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972397 | Ez SprayCCQ · Traditional | Intertex Research, Inc. | 09/23/1997SE |
| K964956 | E-Z Spacer Mask (Small)CCQ · Traditional | Airpharma, LLC | 04/23/1997SE |
| K961894 | Mdi TutorCCQ · Traditional | Mdi Tutor, Inc. | 08/14/1996SE |
| K960593 | Smartmist Asthma Managment System, Smartmist, Model Number SM-100/SMARTMIST Spirometry…CCQ · Traditional | Aradigm Corp. | 05/10/1996SE |
| K922033 | Saline Solution- SterileCCQ · Traditional | Trinity Laboratories, Inc. | 07/21/1992SE |
| K900576 | Modified Aerochamber with MaskCCQ · Traditional | Monaghan Medical Corp. | 05/13/1991SE |
| K900557 | Modified Aerochamber M.V. Aerosol Holding ChamberCCQ · Traditional | Monaghan Medical Corp. | 04/10/1991SE |
| K895115 | Frank Inhaler Thermal SCCQ · Traditional | Buttner-Frank GmbH | 05/18/1990SE |
| K894215 | Evolution UltrasonicCCQ · Traditional | Medical Industries America, Inc. | 04/16/1990SE |
| K894555 | Pari Inhalierboy Type 37.80 Double InsulatedCCQ · Traditional | Dura Pharmaceuticals, Inc. | 01/24/1990SE |
More from Dura Pharmaceuticals, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K962749 | Therapep W/Mouthpiece, W/Pediatric Mask, W/Small Mask, W/Large Mask…BWF · Traditional | 10/10/1996SE |
| K902713 | Access. Kit for the Biosurge Synchronous AutotransCAC · Traditional | 07/25/1990SE |
| K902114 | Cuff-Mate 2 Endotracheal Cuff Inflator & MonitorBSK · Traditional | 07/18/1990SE |
| K900754 | Respirex 2BWF · Traditional | 03/15/1990SE |
| K893791 | Breathing MouthpieceBYP · Traditional | 06/23/1989SE |
| K781759 | RescalBZA · Traditional | 11/27/1978SE |
| K780750 | O2 ConnectorCAN · Traditional | 07/27/1978SE |
| K770369 | Vacon TMCBD · Traditional | 03/01/1977SE |
| K760931 | I.V. Drip Monitor Alarm Device, MonifloFLN · Traditional | 01/05/1977SE |
| K760636 | OrthomixJDZ · Traditional | 10/05/1976SE |
Questions and answers
When was Medshield/Aerochamber cleared by the FDA?
Medshield/Aerochamber (K961455) received a 510(k) decision of Substantially Equivalent on July 25, 1996, 100 days after the submission was received.
What is the product code of K961455?
The FDA product code is CCQ – Nebulizer, Medicinal, Non-Ventilatory (Atomizer), a Class I (low risk) device regulated under 21 CFR 868.5640.