Robertazzi Nasopharyngeal Airway
FDA 510(k) K903618 · Eastmed Enterprises, Inc.
510(k) numberK903618
Submission
- Device name
- Robertazzi Nasopharyngeal Airway
- Applicant
- Eastmed Enterprises, Inc.
Marlton, NJ, US - Received
- August 7, 1990
- Decision date
- January 8, 1991
- 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 |
| 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 |
| K850644 | Nasopharyngeal Airway-RobertazziBTQ · Traditional | Dryden Corp. | 03/21/1985SE |
More from Dryden Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K922019 | Laryngoscope RigidCCW · Traditional | 01/26/1993SE |
| K921128 | Endotracheal Tube StyletBSR · Traditional | 06/02/1992SE |
| K914741 | Amer Profile Miller Laryngoscope Blades, ModifiedCCW · Traditional | 02/03/1992SE |
| K901489 | Macintosh Laryngoscope Blades (American Profile)CCW · Traditional | 04/10/1990SE |
| K890342 | Airways (Guedel, Berman & Nasopharyngeal Types)BTO · Traditional | 04/27/1989SE |
| K884584 | Tongue Seizing Forceps with & Without Rubber PadsBWB · Traditional | 11/14/1988SE |
| K884073 | Laryngoscope Blade (Robertshaw Style)CCW · Traditional | 10/13/1988SE |
| K884072 | 15 Millimeter Male and Female AdaptersCAI · Traditional | 10/07/1988SE |
| K882433 | Laryngoscope RigidCCW · Traditional | 09/02/1988SE |
| K882434 | Mask, Gas, AnestheticBSJ · Traditional | 06/30/1988SE |
Questions and answers
When was Robertazzi Nasopharyngeal Airway cleared by the FDA?
Robertazzi Nasopharyngeal Airway (K903618) received a 510(k) decision of Substantially Equivalent on January 8, 1991, 154 days after the submission was received.
What is the product code of K903618?
The FDA product code is BTQ – Airway, Nasopharyngeal, a Class I (low risk) device regulated under 21 CFR 868.5100.