INTROSCOPE— 510(k) K953793
Substantially EquivalentPolamedco, Inc.
FDA 510(k) clearance K953793 for INTROSCOPE, Substantially Equivalent on 1995-11-29. Applicant: Polamedco, Inc.. Device class: 2.
Clearance details
- Applicant
- Polamedco, Inc.
- Product code
- Code BZT
- Device class
- Class 2
- Regulation
- 21 CFR 868.1920
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marina Del Rey, CA, US
Recent devices under product code BZT
view all- K251025 — Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)
- K193027 — Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French
- K140134 — ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL STETHOSCOPE TEMPERATURE WITH ATTACHED EAR PIECE
- K111050 — ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR
- K092716 — ESOPHAGEAL STETHOSCOPE
More clearances from Polamedco, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.