Westmed Respiratory Luer Adaptor
FDA 510(k) K953506 · Westmed Intl.
510(k) numberK953506
Submission
- Device name
- Westmed Respiratory Luer Adaptor
- Applicant
- Westmed Intl.
Tucson, AZ, US - Received
- July 26, 1995
- Decision date
- September 15, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BXY – Flowmeter, Calibration, Gas
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.2350
- Specialty
- Anesthesiology
Other 510(k)s with product code BXY
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|---|---|---|---|
| K902917 | Precision Medical EliminatorBXY · Traditional | Precision Medical, Inc. | 07/23/1990SE |
| K902916 | Precision Medical Neb BlockBXY · Traditional | Precision Medical, Inc. | 07/23/1990SE |
| K863510 | Oxy-Off(Tm)BXY · Traditional | B&B Medical Technologies, Inc. | 10/22/1986SE |
| K860516 | LSP MinilatorBXY · Traditional | Life Support Products, Inc. | 02/21/1986SE |
| K851460 | New Connector & Cover for Telectronics 8MM UnipolaBXY · Traditional | Telectronics, Inc. | 05/10/1985SE |
| K781523 | PFT GasesBXY · Traditional | Gardner Cryogenics | 12/01/1978SE |
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| K924944 | Instant In-Dwell Nasal Suct Tamp/Allevia Nasal TraEMX · Traditional | 07/02/1993SE |
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Questions and answers
When was Westmed Respiratory Luer Adaptor cleared by the FDA?
Westmed Respiratory Luer Adaptor (K953506) received a 510(k) decision of Substantially Equivalent on September 15, 1995, 51 days after the submission was received.
What is the product code of K953506?
The FDA product code is BXY – Flowmeter, Calibration, Gas, a Class I (low risk) device regulated under 21 CFR 868.2350.