Langgasse 90
FDA 510(k) K932470 · Happersberger Otopront GmbH
510(k) numberK932470
Submission
- Device name
- Langgasse 90
- Applicant
- Happersberger Otopront GmbH
Germany, GR - Received
- May 20, 1993
- Decision date
- August 25, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- ETF – Unit, Examining/Treatment, Ent
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.5300
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code ETF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K953457 | Jedmed Spectrum ENT CabinetETF · Traditional | Jedmed Instrument Co. | 08/11/1995SE |
| K945395 | Premier Mirror WarmerETF · Traditional | Premier Dental Products Co. | 01/18/1995SE |
| K911901 | Maxi Cabinet Optional Built in S6000 Light SourceETF · Traditional | Stortz | 07/26/1991SE |
| K910781 | #491 Power Otolaryngoly CH/#498 Proced CTR & AccesETF · Traditional | Midmark Corp. | 05/15/1991SE |
| K910243 | Mobile Treatment CartETF · Traditional | Jedmed Instrument Co. | 04/17/1991SE |
| K896298 | Jedmed S ChairETF · Traditional | Jedmed Instrument Co. | 01/26/1990SE |
| K896273 | Systema ENT CabinetETF · Traditional | Jedmed Instrument Co. | 01/26/1990SE |
| K881958 | Jedmed Maxim ENT CabinetETF · Traditional | Jedmed Instrument Co. | 07/15/1988SE |
| K860940 | Micromedics Sterile, Disposable ENT Exam KitETF · Traditional | Micromedics, Inc. | 05/02/1986SE |
| K855021 | Laryngeal Mirror Pre-WarmerETF · Traditional | Jedmed Instrument Co. | 03/20/1986SE |
Questions and answers
When was Langgasse 90 cleared by the FDA?
Langgasse 90 (K932470) received a 510(k) decision of Substantially Equivalent on August 25, 1993, 97 days after the submission was received.
What is the product code of K932470?
The FDA product code is ETF – Unit, Examining/Treatment, Ent, a Class I (low risk) device regulated under 21 CFR 874.5300.