MP-4400 Mouthpiece-Flange Seal
FDA 510(k) K862788 · Medipart Jerry Alexander
510(k) numberK862788
Submission
- Device name
- MP-4400 Mouthpiece-Flange Seal
- Applicant
- Medipart Jerry Alexander
Cary, IL, US - Received
- July 23, 1986
- Decision date
- August 1, 1986
- 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 |
| 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 |
| K853266 | Plastic Mouth Barrier Hsv-IBYP · Traditional | Westmark Enterprises, Inc. | 10/29/1985SE |
More from Westmark Enterprises, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K896885 | Disposable Respirtory Kit (MP-200)IYT · Traditional | 02/26/1990SE |
| K896125 | Medipart Disposable XENON-133 Rebreathing MP-0133MIYT · Traditional | 02/01/1990SE |
| K896476 | Disp. Radioaerosol Kit (MP-400-M) to Fit ShieldIYT · Traditional | 01/22/1990SE |
| K896475 | Disp. Radioaerosol Kit (MP-400) to Fit Lead ShieldIYT · Traditional | 01/22/1990SE |
| K896124 | Medipart Disposable XENON-133 Rebreathing MP-0133IYT · Traditional | 01/22/1990SE |
| K894138 | Medipart Disposable Aerosol System MP-070-PTDCAF · Traditional | 09/26/1989SE |
| K893532 | Resubmitted Radioaerosol Cont. System MP-963CBN · Traditional | 08/21/1989SE |
| K862795 | MP-070-M Radioaerosol KitIYT · Traditional | 08/01/1986SE |
| K862794 | MP-070 Radioaerosol KitIYT · Traditional | 08/01/1986SE |
| K862793 | MP-066-M Radioaerosol KitIYT · Traditional | 08/01/1986SE |
Questions and answers
When was MP-4400 Mouthpiece-Flange Seal cleared by the FDA?
MP-4400 Mouthpiece-Flange Seal (K862788) received a 510(k) decision of Substantially Equivalent on August 1, 1986, 9 days after the submission was received.
What is the product code of K862788?
The FDA product code is BYP – Mouthpiece, Breathing, a Class I (low risk) device regulated under 21 CFR 868.5620.