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FDA 510(k)

CADD-1, MODEL 5100 HF

K-Number: K862927 · 1986-08-27

ApplicantDeltec Systems, Inc.
Decision Date1986-08-27
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CADD-1, MODEL 5100 HF is the device name listed in this FDA 510(k) record. The listed applicant is Deltec Systems, Inc.. It received FDA 510(k) clearance on 1986-08-27 under 510(k) number K862927. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CADD-1, MODEL 5100 HF?

CADD-1, MODEL 5100 HF is a medical device that received FDA 510(k) clearance on 1986-08-27. The listed applicant is Deltec Systems, Inc.. The 510(k) number is K862927.

When did CADD-1, MODEL 5100 HF receive FDA 510(k) clearance?

CADD-1, MODEL 5100 HF received FDA 510(k) clearance on 1986-08-27, under 510(k) number K862927.

Who is the listed applicant for CADD-1, MODEL 5100 HF?

The FDA 510(k) record lists Deltec Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CADD-1, MODEL 5100 HF?

The FDA product code for CADD-1, MODEL 5100 HF is FRN.

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Other records listing Deltec Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K871132PHARMACIA DELTEC SUBCLAVIAN INTRODUCERSK870768AC ADAPTER ACCESSORY, PRODUCT CODE 600123AK854964CADD-LD 5500 AMBU INFUSION PUMP&3010 10ML MED RES.K853584CADD-1, MODEL 5100 HF, AMBULATORY INFUSION PUMPK850183CADD-VT, 5300 AMBULATORY INFUSION PUMP W/3050, 50MK843773CADD-PAC 5200 AMBULATORY INFUSION PUMP

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Related Devices (Code: FRN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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