510(k) K862548
- Device
- TEMPERATURE SENSING ESOPHAGEAL TRANSDUCER
- Applicant
- Lawrence Medical Systems, Inc.
- 510(k) number
- K862548
- Product code
- BZT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-10-22
- Date received
- 1986-07-03
- Regulation
- 868.1920
- Classification name
- Stethoscope, Esophageal, With Electrical Conductors
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD LEARY
- Address
- 14910 NE 31st Cir. Redmond WA US 98052 98052
FDA Registration Numbers#
- 9681384
- 1721686
- 2527072
- 1927197
- 1043214
- 3007007790
- 2246552
- 3023031046
- 8022257
- 1055236
- 3006845683
- 3006845687
- 9617604
- 2030624
- 2032112
- 3018094310
- 2032273
- 3012307300
- 1054241
- 2432320
- 2936999
- 1928237
- 9613793
- 3003915875
Source Documents#
510(k) summary PDF not indicated by FDA
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| K961060 | ARISTO ESOPHAGEAL STETHOSCOPE | Aristo Medical Products, Inc. | 1996-06-19 |
| K953793 | INTROSCOPE | Polamedco, Inc. | 1995-11-29 |
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| K943495 | DISPOSABLE ESOPHAGEAL STETHOSCOPE | Coast Medical, Inc. | 1994-09-08 |
| K940169 | DEBUSK TEMPERATURE SYSTEMS PREMIER AND SIGNATURE SERIES MULTI-PURPOSE ESOPHAGEAL STETHOSCOPE | Deroyal Industries, Inc. | 1994-07-28 |
| K925789 | DEBUSK TEMP. SYST. ESOPHAGEAL STETHOSCOPE | Deroyal Industries, Inc. | 1993-07-13 |