PHYSIOLOGICAL RECORDER MODEL 740
FDA 510(k) clearance K772054 · decided 1977-11-22
Clearance details
- K-number
- K772054
- Device name
- PHYSIOLOGICAL RECORDER MODEL 740
- Applicant
- Datascope Corp.
- Decision
- Substantially Equivalent
- Date received
- 1977-10-31
- Decision date
- 1977-11-22
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- DSF
- Device class
- 1
- Regulation number
- 870.2810
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EDENTEC DIGITAL CHARTER MODEL 3710 (K910871) | Edentec Corp. | 1991-08-29 |
| DASH IV (K912929) | Astro-Med, Inc. | 1991-08-13 |
| MODEL 556 MONITOR (K905856) | Ge Medical Systems Information Technologies | 1991-01-11 |
| GRI LASERGRAPH(TM) ECG PAPER (K902586) | Gri Medical Products, Inc. | 1990-06-22 |
| COLORADO COLOR IMAGING RECORDER (K902230) | Honeywell, Inc. | 1990-06-19 |
| GABRIEL MEDICAL CLS THERMAL RECORDER (K901385) | Gabriel Medical, Inc. | 1990-05-09 |
| TYPE 9541 RECORDER, PAPER CHART (K895111) | S & W Medico Teknik | 1990-01-26 |
| WR3500 AND WR3600 SERIES RECORDERS (K894922) | Western Graphtec | 1990-01-26 |
| MT96000 PAPER CHART RECORDER (K894736) | Astro-Med, Inc. | 1989-12-13 |
| PAQ10 PAPER CHART RECORDER (K894607) | Protocol Systems, Inc. | 1989-10-26 |
| EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM. (K893561) | Edentec Corp. | 1989-08-25 |
| CARDIOCAP(TM) DR-104 REPORTER (K885058) | Datex Division Instrumentarium Corp. | 1989-07-14 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ABSORBABLE COLLAGEN HEMOSTAT (P850023/S014) | Datascope Corp. | 1994-12-22 |
| HEMOPAD(TM) ABSORBABLE COLLAGEN HEMOSTAT (P850023/S010) | Datascope Corp. | 1992-11-16 |
| ABSORBABLE COLLAGEN HEMOSTAT (P850023/S013) | Datascope Corp. | 1992-08-26 |
| HEMAFLEX (TM) MED-CHEM PRODUCTS,DISTRIBUTOR (P850023/S011) | Datascope Corp. | 1991-10-04 |
| NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT (P850023/S009) | Datascope Corp. | 1990-09-28 |
| NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT (P850023/S005) | Datascope Corp. | 1989-05-17 |
| NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT (P850023/S008) | Datascope Corp. | 1989-03-09 |
| NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT (P850023/S006) | Datascope Corp. | 1988-09-09 |