Disposable Mouthpiece
FDA 510(k) K791537 · Hospitak, Inc.
510(k) numberK791537
Submission
- Device name
- Disposable Mouthpiece
- Applicant
- Hospitak, Inc.
Mchenry, IL, US - Received
- August 10, 1979
- Decision date
- September 7, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BYP – Mouthpiece, Breathing
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5620
- Specialty
- Anesthesiology
Other 510(k)s with product code BYP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K955657 | North State Plastics Respiratory MouthpieceBYP · Traditional | North State Plastics, Inc. | 03/12/1996SE |
| K944512 | Truzone PFM Disposable MouthpieceBYP · Traditional | Monaghan Medical Corp. | 11/02/1994SE |
| K893791 | Breathing MouthpieceBYP · Traditional | Diemolding Corp. | 06/23/1989SE |
| K872037 | AerochamberBYP · Traditional | Monaghan Medical Corp. | 07/24/1987SE |
| K865093 | Safe-T-Shield MouthpieceBYP · Traditional | Medi Nuclear Corp., Inc. | 01/15/1987SE |
| K863049 | Inhalation AidBYP · Traditional | Boehringer Ingelheim Pharmaceuticals, Inc. | 10/15/1986SE |
| K862788 | MP-4400 Mouthpiece-Flange SealBYP · Traditional | Medipart Jerry Alexander | 08/01/1986SE |
| K853575 | Medipart Mouthpiece MP-1010BYP · Traditional | Medipart Jerry Alexander | 10/29/1985SE |
| K853574 | Medipart Dispos. Mouthpiece W/22MM O.D. MP-4411BYP · Traditional | Medipart Jerry Alexander | 10/29/1985SE |
| K853572 | Medipart Dispos. Mouthpiece W/2MM I.D. MP-4410BYP · Traditional | Medipart Jerry Alexander | 10/29/1985SE |
More from Medipart Jerry Alexander
| 510(k) | Device | Decision |
|---|---|---|
| K955483 | Trach Mask Model (245, 246)BYF · Traditional | 02/28/1996SE |
| K954787 | IlluminatorCCW · Traditional | 01/31/1996SE |
| K953620 | Warm N Wet Hmef W/Luer AdapterBYD · Traditional | 08/25/1995SE |
| K953619 | Warm N Wet Hme W/Luer AdapterBYD · Traditional | 08/25/1995SE |
| K915750 | Disposable Bacterial Breathng FilterCAH · Traditional | 11/30/1994SE |
| K920842 | Aerosol Delivery SystemsLRD · Traditional | 05/15/1992SE |
| K915228 | Disposable CO2 Gas Sampling/Oxygen Delivery CannulCCK · Traditional | 02/11/1992SE |
| K873286 | Disposable, Manual Pulmonary ResuscitatorBTM · Traditional | 10/26/1987SE |
| K853600 | Inflatable Air SplintsFZF · Traditional | 09/19/1985SE |
| K844328 | Oxygen ConcentratorCAW · Traditional | 12/04/1984SE |
Questions and answers
When was Disposable Mouthpiece cleared by the FDA?
Disposable Mouthpiece (K791537) received a 510(k) decision of Substantially Equivalent on September 7, 1979, 28 days after the submission was received.
What is the product code of K791537?
The FDA product code is BYP – Mouthpiece, Breathing, a Class I (low risk) device regulated under 21 CFR 868.5620.