BYP — Mouthpiece, Breathing Class I
FDA Device Classification
Classification Details
- Product Code
- BYP
- Device Class
- Class I
- Regulation Number
- 868.5620
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K955657 | north state plastics | NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE | March 12, 1996 |
| K944512 | monaghan medical | TRUZONE PFM DISPOSABLE MOUTHPIECE | November 2, 1994 |
| K893791 | diemolding | BREATHING MOUTHPIECE | June 23, 1989 |
| K872037 | monaghan medical | AEROCHAMBER | July 24, 1987 |
| K865093 | medi nuclear corp | SAFE-T-SHIELD MOUTHPIECE | January 15, 1987 |
| K863049 | boehringer ingelheim pharmaceuticals | INHALATION AID | October 15, 1986 |
| K862788 | medipart jerry alexander | MP-4400 MOUTHPIECE-FLANGE SEAL | August 1, 1986 |
| K853574 | medipart jerry alexander | MEDIPART DISPOS. MOUTHPIECE W/22MM O.D. MP-4411 | October 29, 1985 |
| K853575 | medipart jerry alexander | MEDIPART MOUTHPIECE MP-1010 | October 29, 1985 |
| K853266 | westmark enterprises | PLASTIC MOUTH BARRIER HSV-I | October 29, 1985 |
| K853572 | medipart jerry alexander | MEDIPART DISPOS. MOUTHPIECE W/2MM I.D. MP-4410 | October 29, 1985 |
| K853402 | e-z-em | E-Z-GUARD MOUTHPIECE | October 23, 1985 |
| K840459 | kinetix | IMPROVED MOUTHPIECE | February 17, 1984 |
| K833420 | kinetix | KINETIX MOUTHPIECE | January 10, 1984 |
| K822437 | monaghan medical | MONAGHAN AEROCHAMBER | November 3, 1982 |
| K821128 | airlife | DISPOSABLE THERMOPLASTIC RUBBER MOUTH | May 13, 1982 |
| K810793 | dhd medical products div. diemolding | MOUTHPIECE, BREATHING | May 5, 1981 |
| K803069 | warren e. collins | SHELL KRATON THERMO-PLASTIC RUBBER COMP. | December 22, 1980 |
| K791537 | hospitak | DISPOSABLE MOUTHPIECE | September 7, 1979 |
| K790933 | mem medical | MOUTHPIECE M-187 | May 21, 1979 |