Interspec Apogee Cla
FDA 510(k) K924231 · Interspec, Inc.
510(k) numberK924231
Submission
- Device name
- Interspec Apogee Cla
- Applicant
- Interspec, Inc.
Ambler, PA, US - Received
- August 21, 1992
- Decision date
- June 14, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K940671 | Interspec Apogee RX400 Ultrasound Imaging System and Doppler Ultrasound FlowmeterITX · Traditional | 11/22/1994SE |
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| K911073 | Probe Refill KitITX · Traditional | 06/06/1991SE |
| K910049 | Interspec Apogee, ModificationDPW · Traditional | 04/29/1991SE |
| K903839 | Interspec ApogeeDXK · Traditional | 11/16/1990SE |
| K900155 | Interspec 2 MHZ, Transcranial Pulsed Wave DopplerITX · Traditional | 10/05/1990SE |
| K892944 | Interspec Transesophageal Probe Model 4515JOP · Traditional | 07/19/1989SE |
| K890173 | Interspec ApogeeIYO · Traditional | 04/14/1989SE |
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Questions and answers
When was Interspec Apogee Cla cleared by the FDA?
Interspec Apogee Cla (K924231) received a 510(k) decision of Substantially Equivalent on June 14, 1993, 297 days after the submission was received.
What is the product code of K924231?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.