Gentlehaler(R)
FDA 510(k) K892117 · Schering Research
510(k) numberK892117
Submission
- Device name
- Gentlehaler(R)
- Applicant
- Schering Research
Kenilworth, NJ, US - Received
- March 31, 1989
- Decision date
- June 23, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K961455 | Medshield/AerochamberCCQ · Traditional | Diemolding Corp. | 07/25/1996SE |
| 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 |
Questions and answers
When was Gentlehaler(R) cleared by the FDA?
Gentlehaler(R) (K892117) received a 510(k) decision of Substantially Equivalent on June 23, 1989, 84 days after the submission was received.
What is the product code of K892117?
The FDA product code is CCQ – Nebulizer, Medicinal, Non-Ventilatory (Atomizer), a Class I (low risk) device regulated under 21 CFR 868.5640.