Medipart Face Mask Headstrap MP-9100
FDA 510(k) K853573 · Medipart Jerry Alexander
510(k) numberK853573
Submission
- Device name
- Medipart Face Mask Headstrap MP-9100
- Applicant
- Medipart Jerry Alexander
Cary, IL, US - Received
- August 26, 1985
- Decision date
- October 29, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BTK – Strap, Head, Gas Mask
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5560
- Specialty
- Anesthesiology
Other 510(k)s with product code BTK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K944949 | General Anesthesia SystemBTK · Traditional | Vital Signs, Inc. | 11/14/1994SESK |
| K914335 | Strap, Head, Gas MaskBTK · Traditional | Vital Signs, Inc. | 04/02/1992SE |
| K854537 | HeadstrapBTK · Traditional | Life Design Systems, Inc. | 12/03/1985SE |
| K831008 | Head StrapBTK · Traditional | Medovations, Inc. | 05/09/1983SE |
| K810991 | HeadstrapBTK · Traditional | Respironics, Inc. | 04/29/1981SE |
More from Respironics, 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 Medipart Face Mask Headstrap MP-9100 cleared by the FDA?
Medipart Face Mask Headstrap MP-9100 (K853573) received a 510(k) decision of Substantially Equivalent on October 29, 1985, 64 days after the submission was received.
What is the product code of K853573?
The FDA product code is BTK – Strap, Head, Gas Mask, a Class I (low risk) device regulated under 21 CFR 868.5560.