Interspec Apogee, Modification
FDA 510(k) K910049 · Interspec, Inc.
510(k) numberK910049
Submission
- Device name
- Interspec Apogee, Modification
- Applicant
- Interspec, Inc.
Ambler, PA, US - Received
- January 7, 1991
- Decision date
- April 29, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DPW – Flowmeter, Blood, Cardiovascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2100
- Specialty
- Cardiovascular
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| K252810 | FloPatch FP120DPW · Special | Flosonics Medical | 04/24/2026SE |
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| K243852 | Elfor-LDPW · Traditional | Elfi-Tech , Ltd. | 04/14/2025SE |
| K241583 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger…DPW · Special | Remington Medical, Inc. | 08/30/2024SE |
| K223843 | FloPatch FP120DPW · Traditional | Flosonics Medical | 05/03/2023SE |
| K222242 | FloPatch FP120DPW · Traditional | Flosonics Medical | 12/09/2022SE |
| K213974 | GEM FLOW COUPLER Monitor (GEM1020M-2)DPW · Special | Synovis Micro Companies Alliance, Inc. | 04/20/2022SE |
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More from Remington Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K940671 | Interspec Apogee RX400 Ultrasound Imaging System and Doppler Ultrasound FlowmeterITX · Traditional | 11/22/1994SE |
| K924231 | Interspec Apogee ClaIYO · Traditional | 06/14/1993SE |
| K915696 | Interspec Apogee Endo-V Probe and Needle GuideITX · Traditional | 11/24/1992SE |
| K920678 | Ultrasound Imagaing System and Doppler FlowmeterITX · Traditional | 04/02/1992SE |
| K911073 | Probe Refill KitITX · Traditional | 06/06/1991SE |
| 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, Modification cleared by the FDA?
Interspec Apogee, Modification (K910049) received a 510(k) decision of Substantially Equivalent on April 29, 1991, 112 days after the submission was received.
What is the product code of K910049?
The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.