Fitness Recumbent Ergometer, Model FT1400
FDA 510(k) K872548 · Invacare Corp.
510(k) numberK872548
Submission
- Device name
- Fitness Recumbent Ergometer, Model FT1400
- Applicant
- Invacare Corp.
Elyria, OH, US - Received
- June 29, 1987
- Decision date
- December 15, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DPS – Electrocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2340
- Specialty
- Cardiovascular
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|---|---|---|---|
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| K241556 | Cardiac Workstation (5000); Cardiac Workstation (7000)DPS · Traditional | Philips Medizin Systeme Böblingen GmbH | 12/17/2024SE |
| K240229 | Masimo W1DPS · Traditional | Masimo Corporation | 08/08/2024SE |
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Questions and answers
When was Fitness Recumbent Ergometer, Model FT1400 cleared by the FDA?
Fitness Recumbent Ergometer, Model FT1400 (K872548) received a 510(k) decision of Substantially Equivalent on December 15, 1987, 169 days after the submission was received.
What is the product code of K872548?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.