Nasopharyngeal Airway-Robertazzi Style
FDA 510(k) K831476 · Fls Medical Products, Inc.
510(k) numberK831476
Submission
- Device name
- Nasopharyngeal Airway-Robertazzi Style
- Applicant
- Fls Medical Products, Inc.
Walker, MI, US - Received
- May 9, 1983
- Decision date
- June 10, 1983
- 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 |
|---|---|---|
| K853828 | FLS Med. Prod. Racine Type AdaptorBZA · Traditional | 10/29/1985SE |
Questions and answers
When was Nasopharyngeal Airway-Robertazzi Style cleared by the FDA?
Nasopharyngeal Airway-Robertazzi Style (K831476) received a 510(k) decision of Substantially Equivalent on June 10, 1983, 32 days after the submission was received.
What is the product code of K831476?
The FDA product code is BTQ – Airway, Nasopharyngeal, a Class I (low risk) device regulated under 21 CFR 868.5100.