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510(k) K801462

SPOR-O-THERM by Mdt Corp., Inc. — Product Code JTQ

K801462 is an FDA 510(k) premarket notification submitted by Mdt Corp., Inc. for the device "SPOR-O-THERM". The FDA issued a decision of Substantially Equivalent on July 28, 1980. The device falls under product code JTQ (Bath, Incubators/Water, All), a Class I device regulated under 21 CFR 866.2540. Mdt Corp., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1980
Date Received
June 24, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bath, Incubators/Water, All
Device Class
Class I
Regulation Number
866.2540
Review Panel
MI
Submission Type

Other clearances by Mdt Corp., Inc.

  • K960777 — MDT UNISPORE AND SPOR-TEST BIOLOGICALINDICATOR (May 23, 1996)
  • K942485 — MDT UROLOGY TABLE (August 26, 1994)
  • K942486 — IMAGE FULL POWER EXAMINATION/MINOR SURGERY TABLE (August 10, 1994)
  • K924380 — MDT/HARVEY MODEL 7000 & 8000 CHEMICLAVE (February 16, 1994)
  • K926081 — DENTAL LIGHT (January 26, 1994)
  • K924955 — MDT/HARVEY MC-8 AND MC-10 (October 15, 1993)
  • K932094 — BOVIE ULTRASONIC SURGICAL ASPIRATOR (July 21, 1993)
  • K931169 — MDT DENTAL CHAIR (May 20, 1993)
  • K920930 — MDT/CASTLE 10/90 DUAL LOAD STATION (March 31, 1993)
  • K922212 — MDT CASTLE BIOSIGN TEST PACK (August 10, 1992)

Other clearances for product code JTQ

  • K875275 — WINTHROP PHARMACEUTICALS CONTRAST MEDIA WARMER (January 27, 1988)
  • K853379 — PLATE INCUBATOR (September 3, 1985)
  • K831592 — ANHYDRIC INCUBATORS, CULTURE INCUBATOR (June 16, 1983)
  • K830322 — C.A.T. REAGENT KIT (March 28, 1983)
  • K830227 — AUTOMATED ELISA READER LBI 300 (March 10, 1983)
  • K830405 — LBI-100 37DEGREES INCUBATOR (March 10, 1983)
  • K822564 — WATER BATH (September 14, 1982)
  • K812826 — FORMA CH/P GAS PROCESSOR (October 23, 1981)
  • K812340 — TITERTEK MICROPLATE INCUBATOR (September 23, 1981)
  • K792060 — TEMPTRONIC 100 WATER BATH (December 4, 1979)

FDA data resources