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510(k) K790644

SUBMAX by Chase Mfg. Co. — Product Code DRT

K790644 is an FDA 510(k) premarket notification submitted by Chase Mfg. Co. for the device "SUBMAX". The FDA issued a decision of Substantially Equivalent on April 26, 1979. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. Chase Mfg. Co. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 1979
Date Received
March 30, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

Other clearances by Chase Mfg. Co.

  • K791513 — ADAMCO DUST COVER (October 11, 1979)
  • K790993 — INSTANT HOT & COLD PACKS (September 7, 1979)
  • K780033 — MATTRESSES, CONDUCTIVE & COVERS (February 21, 1978)
  • K771792 — ENEMA SET (October 20, 1977)
  • K771791 — NEEDLE COUNTING (October 4, 1977)
  • K770900 — CAST BRWM, FRACTURE (July 21, 1977)
  • K770898 — FRACTURE CAST BRACE KIT, PLASTIC (July 21, 1977)
  • K770899 — FRACTURE CAST BRACE, POLY (July 21, 1977)
  • K770173 — STOCKINETTE (February 8, 1977)

Other clearances for product code DRT

  • K261286 — The Circadia C300 System (C300) (May 20, 2026)
  • K252676 — The Circadia C300 System (C300) (February 3, 2026)
  • K253388 — Sleepiz One+ (Model 2.5) (January 28, 2026)
  • K251364 — Sleepiz One+ (2.5) (July 29, 2025)
  • K234003 — The Circadia C200 System (May 30, 2024)
  • K232354 — Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central (March 22, 2024)
  • K231733 — Neteera 130H-Plus Vital Sign Monitoring Sensor (February 9, 2024)
  • K223163 — Sleepiz One+ (August 18, 2023)
  • K212143 — Neteera 130H/131H Vital Sign Monitoring Sensor (September 28, 2022)
  • K202138 — Cardiac Trigger Monitor (May 14, 2021)

FDA data resources