Ventlab Bacterial Filter, Model BF100
FDA 510(k) K030271 · Ventlab Corp.
510(k) numberK030271
Submission
- Device name
- Ventlab Bacterial Filter, Model BF100
- Applicant
- Ventlab Corp.
Mocksville, NC, US - Received
- January 27, 2003
- Decision date
- July 7, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CAH – Filter, Bacterial, Breathing-Circuit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5260
- Specialty
- Anesthesiology
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| K063813 | Ventlab Nasal CO2 SAMPLING/O2 Delivery CannulaCCK · Traditional | 03/26/2008SE |
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Questions and answers
When was Ventlab Bacterial Filter, Model BF100 cleared by the FDA?
Ventlab Bacterial Filter, Model BF100 (K030271) received a 510(k) decision of Substantially Equivalent on July 7, 2003, 161 days after the submission was received.
What is the product code of K030271?
The FDA product code is CAH – Filter, Bacterial, Breathing-Circuit, a Class II (moderate risk) device regulated under 21 CFR 868.5260.