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510(k) K770944

INSTATEMP by H.I. Silverman, D.Sc. — Product Code KDP

K770944 is an FDA 510(k) premarket notification submitted by H.I. Silverman, D.Sc. for the device "INSTATEMP". The FDA issued a decision of Substantially Equivalent on July 27, 1977. The device falls under product code KDP (Regulator, Vacuum), a Class II device regulated under 21 CFR 880.6740.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1977
Date Received
May 25, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Regulator, Vacuum
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

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  • K933232 — BOEHRINGER LABORATORIES SUCTION REGULATOR, MODIFIED (March 28, 1994)
  • K926140 — VACUUM POWER BODY FLUID SUCTION APPARATUS (July 27, 1993)
  • K922817 — PM3000 & PM3100 VACUUM REGULATOR (March 4, 1993)
  • K883229 — OHMEDA CONTINUOUS SUCTION REGULATOR (October 19, 1988)
  • K875074 — VACUMATE INTERMITTENT/CONTINUOUS CONTROLLER,VM2000 (February 22, 1988)
  • K853155 — BOEHRINGER LAB SUCTION INTERRUPTER (October 16, 1985)
  • K850200 — SUCTION REGULATOR 7700 SERIES (March 4, 1985)

FDA data resources