Nasopharyngeal Airway-Robertazzi
FDA 510(k) K850644 · Dryden Corp.
510(k) numberK850644
Submission
- Device name
- Nasopharyngeal Airway-Robertazzi
- Applicant
- Dryden Corp.
Indianapolis, IN, US - Received
- February 19, 1985
- Decision date
- March 21, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BTQ – Airway, Nasopharyngeal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5100
- Specialty
- Anesthesiology
Other 510(k)s with product code BTQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K940320 | Ad-Tech's Raab Infant Nasopharyngeal ProngsBTQ · Traditional | Ad-Tech Medical Instrument Corp | 09/19/1995SE |
| K921353 | Nasopharyngeal AirwayBTQ · Traditional | Coast Medical Corp. | 06/11/1992SE |
| K911784 | Nortec Robertazzi Nasopharyngeal AirwayBTQ · Traditional | North American Sterilization & Packaging Co. | 09/23/1991SE |
| K903618 | Robertazzi Nasopharyngeal AirwayBTQ · Traditional | Eastmed Enterprises, Inc. | 01/08/1991SE |
| K900456 | Polamedco Nasopaharyngeal AirwayBTQ · Traditional | Polamedco, Inc. | 04/19/1990SE |
| K901279 | Chatham Industries Nasopharyngeal AirwayBTQ · Traditional | Chatham Industries | 03/28/1990SE |
| K883668 | Sunderland Nasal TubeBTQ · Traditional | Exmoor Plastics , Ltd. | 11/21/1988SE |
| K873949 | Rorertazzi Nasopharyngeal AirwayBTQ · Traditional | Penn Medical Devices, Inc. | 10/20/1987SE |
| K871673 | Nasopharyngeal AirwayBTQ · Traditional | Harding Industries, Inc. | 06/15/1987SE |
| K853162 | Sterile Nasopharyngeal AirwayBTQ · Traditional | Inmed Corp. | 08/06/1985SE |
More from Inmed Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K880923 | Patient Ventilator IsolatorCBK · Traditional | 09/06/1988SE |
| K880769 | Breathing Circuit W/Heated WireBZE · Traditional | 08/24/1988SE |
| K882285 | Nonrebreathing CircuitBTM · Traditional | 08/16/1988SE |
| K873928 | Universal TourniquetGAX · Traditional | 10/23/1987SE |
| K873927 | Reuseable Breathing TubesBZO · Traditional | 10/20/1987SE |
| K870859 | Bag-Tail Bleed ValveCAI · Traditional | 08/03/1987SE |
| K871386 | Breathing CircuitCAI · Traditional | 05/29/1987SE |
| K870858 | Badgwell Sampling CatheterCCK · Traditional | 05/14/1987SE |
| K861540 | Disposable Berman and Guedel AirwaysCAE · Traditional | 05/02/1986SE |
| K842843 | Dryden Scavenger Interface System · Traditional | 07/27/1984SE |
Questions and answers
When was Nasopharyngeal Airway-Robertazzi cleared by the FDA?
Nasopharyngeal Airway-Robertazzi (K850644) received a 510(k) decision of Substantially Equivalent on March 21, 1985, 30 days after the submission was received.
What is the product code of K850644?
The FDA product code is BTQ – Airway, Nasopharyngeal, a Class I (low risk) device regulated under 21 CFR 868.5100.