Datex-Ohmeda Hmef 750
FDA 510(k) K031653 · Datex-Ohmeda
510(k) numberK031653
Submission
- Device name
- Datex-Ohmeda Hmef 750
- Applicant
- Datex-Ohmeda
Needham, MA, US - Received
- May 28, 2003
- Decision date
- June 20, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary 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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| K221836 | Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusCAH · Traditional | Drägerwerk AG & Co. KGaA | 12/07/2022SE |
| K221250 | EasyOne FilterCAH · Traditional | Ndd Medizintechnik AG | 11/22/2022SE |
| K210352 | GGM Breathing Circuit Bacterial FilterCAH · Traditional | Great Group Medical Co, Ltd. | 03/27/2022SE |
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Questions and answers
When was Datex-Ohmeda Hmef 750 cleared by the FDA?
Datex-Ohmeda Hmef 750 (K031653) received a 510(k) decision of Substantially Equivalent on June 20, 2003, 23 days after the submission was received.
What is the product code of K031653?
The FDA product code is CAH – Filter, Bacterial, Breathing-Circuit, a Class II (moderate risk) device regulated under 21 CFR 868.5260.