Medcare Regional Anethesia Kit
FDA 510(k) K961075 · Medcare Medical Group, Inc.
510(k) numberK961075
Submission
- Device name
- Medcare Regional Anethesia Kit
- Applicant
- Medcare Medical Group, Inc.
East Swanzey, NH, US - Received
- March 18, 1996
- Decision date
- September 6, 1996
- Decision
- Unknown (SEKD)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAZ – Anesthesia Conduction Kit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5140
- Specialty
- Anesthesiology
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
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More from Smiths Medical Asd, Inc.
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|---|---|---|
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| K962849 | Catheter Insertion TrayLJS · Traditional | 10/07/1996SE |
| K962328 | Single Use Instrument TrayFSM · Traditional | 08/09/1996SE |
| K962527 | General Purpose Dental TrayEIA · Traditional | 08/01/1996SE |
| K961880 | Medcare Suction Connecting TubingGCX · Traditional | 07/19/1996SE |
| K961167 | Medcare Tracheostomy Care TrayLRQ · Traditional | 07/02/1996SESK |
Questions and answers
When was Medcare Regional Anethesia Kit cleared by the FDA?
Medcare Regional Anethesia Kit (K961075) received a 510(k) decision of Unknown on September 6, 1996, 172 days after the submission was received.
What is the product code of K961075?
The FDA product code is CAZ – Anesthesia Conduction Kit, a Class II (moderate risk) device regulated under 21 CFR 868.5140.