Aerosol Delivery Systems
FDA 510(k) K920842 · Hospitak, Inc.
510(k) numberK920842
Submission
- Device name
- Aerosol Delivery Systems
- Applicant
- Hospitak, Inc.
Lindenhurst, NY, US - Received
- February 24, 1992
- Decision date
- May 15, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LRD – Applicator, Ent Drug
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.5220
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code LRD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K984345 | AromapatchLRD · Traditional | Envis, Inc. | 03/19/1999SE |
| K932522 | Amsco Sterile Recoveries Surgical PacksLRD · Traditional | Amsco Sterile Recoveries, Inc. | 09/09/1994SE |
| K942789 | MistassistLRD · Traditional | The Merlin Corp. | 08/12/1994SE |
| K940133 | The Expandacell Ear PackLRD · Traditional | Denver Splint Co. | 05/23/1994SE |
| K925022 | Surgical Tray (Sterile)LRD · Traditional | Customed, Inc. | 04/26/1993SE |
More from Customed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K955483 | Trach Mask Model (245, 246)BYF · Traditional | 02/28/1996SE |
| K954787 | IlluminatorCCW · Traditional | 01/31/1996SE |
| K953620 | Warm N Wet Hmef W/Luer AdapterBYD · Traditional | 08/25/1995SE |
| K953619 | Warm N Wet Hme W/Luer AdapterBYD · Traditional | 08/25/1995SE |
| K915750 | Disposable Bacterial Breathng FilterCAH · Traditional | 11/30/1994SE |
| K915228 | Disposable CO2 Gas Sampling/Oxygen Delivery CannulCCK · Traditional | 02/11/1992SE |
| K873286 | Disposable, Manual Pulmonary ResuscitatorBTM · Traditional | 10/26/1987SE |
| K853600 | Inflatable Air SplintsFZF · Traditional | 09/19/1985SE |
| K844328 | Oxygen ConcentratorCAW · Traditional | 12/04/1984SE |
| K843212 | Low Pressure Alarm for Oxygen CylinderBXH · Traditional | 09/19/1984SE |
Questions and answers
When was Aerosol Delivery Systems cleared by the FDA?
Aerosol Delivery Systems (K920842) received a 510(k) decision of Substantially Equivalent on May 15, 1992, 81 days after the submission was received.
What is the product code of K920842?
The FDA product code is LRD – Applicator, Ent Drug, a Class I (low risk) device regulated under 21 CFR 874.5220.