ESOPHAGEAL STETHOSCOPES
FDA 510(k) clearance K843070 · decided 1984-08-24
Clearance details
- K-number
- K843070
- Device name
- ESOPHAGEAL STETHOSCOPES
- Applicant
- Primrose Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-08-06
- Decision date
- 1984-08-24
- Days to decision
- 18 days
- Clearance type
- Traditional
- Product code
- BZW
- Device class
- 1
- Regulation number
- 868.1910
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- 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 |
|---|---|---|
| MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSOR (K874519) | Mon-A-Therm, Inc. | 1988-01-29 |
| ESOPHAGEAL STETHOSCOPE (K860558) | Sharn, Inc. | 1986-04-01 |
| ESOPHAGEAL STETHOSCOPE (K844444) | Medical Parameters, Inc. | 1985-01-10 |
| ESOPHAGEAL STETHOSCOPE (K842865) | Inmed Corp. | 1984-08-15 |
| QUAZAR ESOPHAGEAL STETHOSCOPE (K841574) | Axiom Medical, Inc. | 1984-08-15 |
| ESOPHAGEAL STETHOSCOPE (K830329) | Science Development Corp. | 1983-03-11 |
| SHERIDAN/ESOPHAGEAL STETHOSCOPE (K830218) | Sheridan Catheter Corp. | 1983-03-09 |
| ESOPHAGEAL STETHOSCOPE (K823703) | Rsp, Inc. | 1983-01-07 |
| MODEL SA-1 STETHOSCOPE AUDIO AMPLIFIER (K823126) | Electromedics, Inc. | 1982-11-16 |
| ESOPHAGEAL STETHESCOPE (K800463) | Medical Components, Inc. | 1980-03-10 |
| ARGYLE ESOPHAGEAL STETHOSCOPE (K790523) | Sherwood Medical Industries | 1979-03-27 |
| ESOPHAGEAL STETH. TEMP. SENSOR (K771411) | Labarge, Inc. | 1977-09-23 |
Recalls involving this device
No recalls on record reference this clearance.