EBS2605 Infant Hugger
FDA 510(k) K892705 · Equilibrated Bio Systems, Inc.
510(k) numberK892705
Submission
- Device name
- EBS2605 Infant Hugger
- Applicant
- Equilibrated Bio Systems, Inc.
Melville, NY, US - Received
- April 14, 1989
- Decision date
- October 27, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BTY – Calculator, Predicted Values, Pulmonary Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1890
- Specialty
- Anesthesiology
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| K223629 | SpiroSphere, SpiroSphereECG, CardioSphereBTY · Traditional | Eresearchtechnology GmbH | 05/28/2024SE |
| K231561 | Pulmonary Function Tester, Model: A9BTY · Traditional | Guangzhou Homesun Medical Technology Co., Ltd. | 02/21/2024SE |
| K222982 | Virtus Metabolic MonitorBTY · Traditional | Virtus Technology Aps | 06/23/2023SE |
| K221030 | Model 9100 PFT/DICOBTY · Traditional | Vitalograph Ireland, Ltd. | 07/15/2022SE |
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| K181912 | Ascent Cardiorespiratory Diagnostic SoftwareBTY · Traditional | Medical Graphics Corporation | 04/12/2019SE |
| K173937 | SpiroSphereBTY · Traditional | Eresearchtechnology GmbH | 02/15/2019SE |
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Questions and answers
When was EBS2605 Infant Hugger cleared by the FDA?
EBS2605 Infant Hugger (K892705) received a 510(k) decision of Substantially Equivalent on October 27, 1989, 196 days after the submission was received.
What is the product code of K892705?
The FDA product code is BTY – Calculator, Predicted Values, Pulmonary Function, a Class II (moderate risk) device regulated under 21 CFR 868.1890.