Lab-Site(R) Safety Cannula
FDA 510(k) K933929 · Migada, Ltd.
510(k) numberK933929
Submission
- Device name
- Lab-Site(R) Safety Cannula
- Applicant
- Migada, Ltd.
Israel, IL - Received
- August 10, 1993
- Decision date
- December 7, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CBF – Chamber, Hyperbaric
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5470
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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| K220290 | Revitalair 430+CBF · Traditional | Us Hyperbaric Network | 05/04/2023SE |
| K171899 | Revitalair 430FCBF · Traditional | Oxavita Srl | 11/22/2019SE |
| K163109 | OxyHeal 4000 Multiplace Hyperbaric Chamber FamilyCBF · Special | Oxyheal Medical Systems, Inc. | 03/22/2017SE |
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| K140559 | Sechrist Monoplace Hyperbaric Oxygen ChamberCBF · Special | Sechrist Industries, Inc. | 05/30/2014SE |
| K102831 | Rsi 4200CBF · Abbreviated | Reimers Systems, Inc. | 08/19/2011SE |
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| K101262 | Flexi-LiteCBF · Traditional | Pressure-Tech, Inc. | 06/10/2010SE |
| K100268 | Sechrist Monoplace Hyperbaric Oxygen ChamberCBF · Special | Sechrist Industries, Inc. | 04/26/2010SE |
More from Sechrist Industries, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K954883 | Free Flow Safety DeviceFPA · Traditional | 04/23/1996SE |
| K943095 | IV Transfer SpikeLHI · Traditional | 09/30/1994SE |
| K902881 | Lab-Site Safety NeedleCBT · Traditional | 09/26/1990SE |
| K870016 | Arterial Blood Gassing Monitoring System (Abg)DTB · Traditional | 05/28/1987SE |
| K864453 | Emergency & Military Infusion SystemFPA · Traditional | 01/20/1987SE |
| K863304 | Preselected Flow Rate I.V. SetFPA · Traditional | 12/09/1986SE |
| K860952 | I.V. Set with and Without Air VentFPA · Traditional | 08/27/1986SE |
| K861275 | High Flow I.V. SetFPA · Traditional | 06/02/1986SE |
| K860595 | Transfer SetLHI · Traditional | 04/07/1986SE |
| K860605 | Filter Set 1) 1.2 Mic Filter 2) 3.0 Mic FilterFPA · Traditional | 03/24/1986SE |
Questions and answers
When was Lab-Site(R) Safety Cannula cleared by the FDA?
Lab-Site(R) Safety Cannula (K933929) received a 510(k) decision of Substantially Equivalent on December 7, 1993, 119 days after the submission was received.
What is the product code of K933929?
The FDA product code is CBF – Chamber, Hyperbaric, a Class II (moderate risk) device regulated under 21 CFR 868.5470.