Interspec Apogee Endo-V Probe and Needle Guide
FDA 510(k) K915696 · Interspec, Inc.
510(k) numberK915696
Submission
- Device name
- Interspec Apogee Endo-V Probe and Needle Guide
- Applicant
- Interspec, Inc.
Ambler, PA, US - Received
- December 23, 1991
- Decision date
- November 24, 1992
- 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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| 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 |
| K863372 | SM-20 Cardioscan Doppler Option with CFM700 ProbesDPT · Traditional | 11/04/1986SE |
Questions and answers
When was Interspec Apogee Endo-V Probe and Needle Guide cleared by the FDA?
Interspec Apogee Endo-V Probe and Needle Guide (K915696) received a 510(k) decision of Substantially Equivalent on November 24, 1992, 337 days after the submission was received.
What is the product code of K915696?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.