Modified DR-2C/PMC 100
FDA 510(k) K896153 · General Devices
510(k) numberK896153
Submission
- Device name
- Modified DR-2C/PMC 100
- Applicant
- General Devices
Bogota, NJ, US - Received
- October 24, 1989
- Decision date
- January 19, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DSH – Recorder, Magnetic Tape, Medical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2800
- Specialty
- Cardiovascular
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| K914889 | Gemscom Series 3000DRG · Traditional | 03/04/1992SE |
| K912008 | Tru-View Multi-Channel DisplayDRT · Traditional | 10/09/1991SE |
| K862596 | DR-2C (Modification)DSF · Traditional | 09/26/1986SE |
| K844650 | DR-2CDXJ · Traditional | 01/22/1985SE |
Questions and answers
When was Modified DR-2C/PMC 100 cleared by the FDA?
Modified DR-2C/PMC 100 (K896153) received a 510(k) decision of Substantially Equivalent on January 19, 1990, 87 days after the submission was received.
What is the product code of K896153?
The FDA product code is DSH – Recorder, Magnetic Tape, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2800.