Westmed Pediatric & Adult Medium Concentration Oxygen Mask
FDA 510(k) K953464 · Westmed, Inc.
510(k) numberK953464
Submission
- Device name
- Westmed Pediatric & Adult Medium Concentration Oxygen Mask
- Applicant
- Westmed, Inc.
Tucson, AZ, US - Received
- July 24, 1995
- Decision date
- September 18, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
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|---|---|---|---|
| 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 |
| 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 |
| K924069 | Surgico Oxygen MaskBYG · Traditional | Gujarat Surgico, Ltd. | 02/04/1993SE |
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| K121382 | Westmed, Inc.'s Blockaide Filter [21 CFR 807.87(A)]CAH · Traditional | 12/06/2012SE |
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| K072220 | Pedi CO2 EasyCCK · Traditional | 08/23/2007SE |
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Questions and answers
When was Westmed Pediatric & Adult Medium Concentration Oxygen Mask cleared by the FDA?
Westmed Pediatric & Adult Medium Concentration Oxygen Mask (K953464) received a 510(k) decision of Substantially Equivalent on September 18, 1995, 56 days after the submission was received.
What is the product code of K953464?
The FDA product code is BYG – Mask, Oxygen, a Class I (low risk) device regulated under 21 CFR 868.5580.