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510(k) K851197

CYBERMEDIC CM-810 BODY PLETHYSMOGRAPH by Cybermedic, Inc. — Product Code JEH

K851197 is an FDA 510(k) premarket notification submitted by Cybermedic, Inc. for the device "CYBERMEDIC CM-810 BODY PLETHYSMOGRAPH". The FDA issued a decision of Substantially Equivalent on July 8, 1985. The device falls under product code JEH (Plethysmograph, Volume), a Class II device regulated under 21 CFR 868.1760. Cybermedic, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1985
Date Received
March 26, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plethysmograph, Volume
Device Class
Class II
Regulation Number
868.1760
Review Panel
AN
Submission Type

Other clearances by Cybermedic, Inc.

  • K941813 — VENSHIELD (May 3, 1994)
  • K914205 — PFF-1 (May 1, 1992)
  • K903959 — NEONATAL METASCOPE (November 23, 1990)
  • K884910 — MODEL 1010, CY-MET (June 12, 1989)
  • K861418 — SPINNAKER (May 9, 1986)
  • K842782 — PHYSIOLOGICAL ANALYZER CM-710 (August 17, 1984)
  • K842760 — LUNG ANALYZER CM-310 (July 26, 1984)
  • K831586 — CM-VII PHYSIOLOGIC ANALYZER (March 19, 1984)
  • K800547 — MEDISTOR III LUNG ANALYZER (March 25, 1980)
  • K790579 — MEDISTOR II (April 4, 1979)

Other clearances for product code JEH

  • K240706 — PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); P (December 9, 2024)
  • K223818 — Model 9160 VitaloQUB (May 25, 2023)
  • K072061 — MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY (April 22, 2008)
  • K022636 — BODY BOX 5500 (January 13, 2003)
  • K960840 — C.E. VASCULAR MACHINE (March 28, 1997)
  • K953642 — AP-18 (December 12, 1995)
  • K951901 — MASTERSCREEN PFT BODY (July 31, 1995)
  • K936108 — MASTERSCREEN BODY (February 3, 1995)
  • K932812 — EC 5R PLETHYSMOGRAPH (January 13, 1994)
  • K925040 — TELEPULSE (August 23, 1993)

FDA data resources