Maska, Oxygen Vinyl D-Sp. Single Use
FDA 510(k) K760219 · Manner Medical Products
510(k) numberK760219
Submission
- Device name
- Maska, Oxygen Vinyl D-Sp. Single Use
- Applicant
- Manner Medical Products
Mchenry, IL, US - Received
- July 12, 1976
- Decision date
- August 3, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BYG – Mask, Oxygen
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5580
- Specialty
- Anesthesiology
Other 510(k)s with product code BYG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K963298 | First Aid Kit(S)BYG · Traditional | Vector, Inc. | 11/06/1996SE |
| K962848 | Hans Rudolph Nasal CPAP MaskBYG · Traditional | Hans Rudolph, Inc. | 10/16/1996SE |
| K945482 | Disposable, CPAP Oxygen MaskBYG · Traditional | Fvtnks | 09/19/1995SE |
| K953464 | Westmed Pediatric & Adult Medium Concentration Oxygen MaskBYG · Traditional | Westmed, Inc. | 09/18/1995SE |
| K953039 | Various Adult & Child High Con/Nonrebreath Oxy MasksBYG · Traditional | Dadsun Corp., Ltd. | 09/15/1995SE |
| K945472 | Westmed Pediatric and Adult Aerosol MaskBYG · Traditional | Westmed Intl. | 02/07/1995SE |
| K942907 | Jemsdal MaskBYG · Traditional | Respan Products, Inc. | 08/31/1994SE |
| K940888 | System 22 Paediatric MaskBYG · Traditional | Medic-Aid , Ltd. | 04/19/1994SE |
| K940887 | System 22 Adult MaskBYG · Traditional | Medic-Aid , Ltd. | 04/19/1994SE |
| K931952 | Medway Oxygen MaskBYG · Traditional | Medway | 08/20/1993SE |
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Questions and answers
When was Maska, Oxygen Vinyl D-Sp. Single Use cleared by the FDA?
Maska, Oxygen Vinyl D-Sp. Single Use (K760219) received a 510(k) decision of Substantially Equivalent on August 3, 1976, 22 days after the submission was received.
What is the product code of K760219?
The FDA product code is BYG – Mask, Oxygen, a Class I (low risk) device regulated under 21 CFR 868.5580.