Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

R&D PART 5518, 5306, 5315 AND 5457

K-Number: K945867 · 1994-12-29

ApplicantR & D Batteries, Inc.
Decision Date1994-12-29
Product CodeFCO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

R&D PART 5518, 5306, 5315 AND 5457 is the device name listed in this FDA 510(k) record. The listed applicant is R & D Batteries, Inc.. It received FDA 510(k) clearance on 1994-12-29 under 510(k) number K945867. The device is classified under product code FCO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the R&D PART 5518, 5306, 5315 AND 5457?

R&D PART 5518, 5306, 5315 AND 5457 is a medical device that received FDA 510(k) clearance on 1994-12-29. The listed applicant is R & D Batteries, Inc.. The 510(k) number is K945867.

When did R&D PART 5518, 5306, 5315 AND 5457 receive FDA 510(k) clearance?

R&D PART 5518, 5306, 5315 AND 5457 received FDA 510(k) clearance on 1994-12-29, under 510(k) number K945867.

Who is the listed applicant for R&D PART 5518, 5306, 5315 AND 5457?

The FDA 510(k) record lists R & D Batteries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for R&D PART 5518, 5306, 5315 AND 5457?

The FDA product code for R&D PART 5518, 5306, 5315 AND 5457 is FCO.

Other records listing R & D Batteries, 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.

K951284R&D BATTERIES, INC. PART NUMBERS 5137, 5140, 5142 AND 5155K951277R&D BATTERIES, INC. PART NUMBERS 5295, 5334, 5344 AND 5410K951285R&D BATTERIES, INC. PART NUMBERS 5158, 5168, 5171 AND 5172K951280R&D BATTERIES, INC. PART NUMBERS 5003, 5006, 5008 AND 5012K951278R&D BATTERIES, INC. PART NUMBERS 5213, 5222, 5268 AND 5284K951276R&D BATTERIES, INC. PART NUMBERS 5412, 5420, 5436 AND 5438

View all 52 devices →

Related Devices (Code: FCO)

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.

K946080PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATORPortable Power Systems, Inc.K945870R&D PART NOS. 5490, 5541, 5358, 5497R & D Batteries, Inc.K944388R&D BATTERIES PART NOS. 5116, 5124, 5099, 5100R & D Batteries, Inc.K944389R&D BATTERIES PART NOS. 5111, 5112, 5065, 5153R & D Batteries, Inc.K944348R&D BATTERIES, INC. PART NO. 5128, 5053, 5007R & D Batteries, Inc.K945868R&D PART NOS. 5262, 5543, 5432, 5469R & D Batteries, Inc.

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.

↑