Physiological Recorder Model 740
FDA 510(k) K772054 · Datascope Corp.
510(k) numberK772054
Submission
- Device name
- Physiological Recorder Model 740
- Applicant
- Datascope Corp.
Mchenry, IL, US - Received
- October 31, 1977
- Decision date
- November 22, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DSF – Recorder, Paper Chart
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.2810
- Specialty
- Cardiovascular
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| K901385 | Gabriel Medical CLS Thermal RecorderDSF · Traditional | Gabriel Medical, Inc. | 05/09/1990SE |
| K895111 | Type 9541 Recorder, Paper ChartDSF · Traditional | S & W Medico Teknik | 01/26/1990SE |
| K894922 | WR3500 and WR3600 Series RecordersDSF · Traditional | Western Graphtec | 01/26/1990SE |
| K894736 | MT96000 Paper Chart RecorderDSF · Traditional | Astro-Med, Inc. | 12/13/1989SE |
| K894607 | PAQ10 Paper Chart RecorderDSF · Traditional | Protocol Systems, Inc. | 10/26/1989SE |
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Questions and answers
When was Physiological Recorder Model 740 cleared by the FDA?
Physiological Recorder Model 740 (K772054) received a 510(k) decision of Substantially Equivalent on November 22, 1977, 22 days after the submission was received.
What is the product code of K772054?
The FDA product code is DSF – Recorder, Paper Chart, a Class I (low risk) device regulated under 21 CFR 870.2810.